Orthopedic device

ABSTRACT

An orthopedic device as in a dorsal splint for treating plantar fasciitis includes a substantially rigid splint member having an overmolded flexible edge and living hinges, or substantially rigid component pieces received in a flexible member, to provide improved and more comfortable fitting to a user and reduced storage requirements. The splint member is shaped and configured to engage the dorsal aspects of a user&#39;s lower leg, ankle, and foot. A soft-good strap system is provided to maintain the dorsal splint in position and has suitable padding to treat various foot conditions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/153,390 filed on May 19, 2008, which claims the benefit of priorityfrom U.S. provisional application Ser. No. 60/924,571 filed on May 21,2007, and U.S. provisional application Ser. No. 60/996,917 filed on Dec.11, 2007.

FIELD OF THE INVENTION

The present invention relates generally to the field of prosthetic andorthopedic devices and more particularly to a dorsal splint for use atnight to treat plantar fasciitis and other foot and heel relateddisorders.

BACKGROUND

Plantar fasciitis is a common problem among people who are active insports, particularly runners. It is also a prevalent problem foroverweight/obese patients and people who remain standing for longperiods of time. It is an inflammation of the plantar fascia, the thicktendon on the bottom of the foot which is attached to the heel bone (thecalcaneus) and fans forwardly to the toes. The plantar fascia maintainsthe arch of the foot and is placed in tension during walking and runningAny sport where the foot lands repeatedly, such as running or jogging,can overload the plantar fascia and produce an inflammation, usually atthe point where the fascia is attached to the heel bone. The reaction ofthe heel bone to the inflammation is often to produce spike-likeprojections of new bone called heel spurs. Both the initial inflammationof the fascia and walking on the heel spurs can cause sharp pain.

A broad range of treatments are prescribed for plantar fasciitis,depending upon the severity of the injury and length of time thecondition has existed. Among the commonly used treatments are rest, ice,anti-inflammatory/analgesic medication, heel pads, taping, physicaltherapy and surgery.

Another form of treatment for the condition is the wearing of a splintor orthosis which maintains the foot in a slightly dorsiflexedcondition, so that the plantar fascia is maintained in a neutral (90degree) or a stretched (below 90 degree) position. Typically, such asplint is prescribed for wear at night while the patient is in bed. Thismaintains a slight stretch of the fascia when it would otherwise beallowed to shorten while the leg and foot muscles are relaxed duringsleep. These so-called “night splints” have taken the following forms.

A first type of a night splint consists of a thick, rigid plasticfootbed and a pair of rigid plastic bars extending vertically upward oneither side of the footbed. A flexible fabric sheath for encircling thefoot and leg is also attached to the foot bed, the sheath being openalong its front so that the patient may put on the entire appliance likea boot. The footbed underlies the entirety of the patient's foot, andthe bars pass along either side of the ankle and lower leg. Straps areattached to the footbed and the bars, and are fastened around the footand lower leg respectively to secure the splint in position and somaintain the patient's foot in the proper, slightly flexed orientation.Such splints are quite heavy and bulky, and it is common for patients tocomplain that they are uncomfortable and interfere with sleep.

A second type of a night splint is a generally L-shaped brace made of arelatively thin layer of molded plastic such as polypropylene. Theforward-facing surface of the brace is substantially concave to fitaround the rear and sides of the patient's calf, ankle and heel. Thebottom portion of the “L” extends forwardly beneath the sole of thefoot. These splints generally are lined with padding made from a foam orsynthetic pile, and are held in place on the lower leg and foot by meansof adjustable straps, typically secured with hook-and-pile fasteners.While such splints are less bulky than the first type of prior artsplint, some patients still complain that they are uncomfortable,particularly when worn in bed. The rigid portion of the splint contactsthe rear and sides of the heel, ankle and lower leg, and so comesbetween the patient and the bed mattress during most sleeping postures.The splints may be so uncomfortable that patients cannot get a normalnight's rest or may discontinue use of the splint before it has achievedthe desired therapeutic result.

A third type of orthopedic device for the treatment of plantar fasciitisis known as a foot sling. The foot sling consists of a wide band offlexible, padded material which encircles the patient's lower leg justbelow the knee, and a flexible strap which passes beneath the ball ofthe patient's foot and is secured at its ends to the upper leg band oneither side of the leg. The strap is tightened to pull upwardly on thefoot and so maintain it in a dorsi-flexed position. The foot sling maybe uncomfortable to some patient's since the upper leg band must betight enough around the leg to prevent it from slipping downward whenthe strap is tightened.

A fourth type of a night splint consists of a rigid plastic, generally“L” shaped brace configured to fit along the dorsal surfaces of theuser's foot, ankle and lower leg (a “dorsal” splint). A cloth cover maybe provided over each end of the “L” shape in order to provide someinterface between the rigid brace and the user's skin, and straps thatencircle the brace as well as the foot, ankle, and lower leg, may beconnected to the cloth cover to tighten the brace in position. Whilethis type of brace solves some of the problems associated with thepreviously discussed devices, there still exist issues of patientcomfort, as well as the comfort of any person sharing a bed with thepatient wearing such a brace. In order for the brace to properlyfunction, it must be substantially rigid, such that the extendingportions of the brace will not closely conform to the user's foot,ankle, and lower leg. Thus the brace will not have a good and securefit. Further, due to the typical injection molding formation of thebrace, the edges of the brace may be sharp and cause irritation. Thecloth covers do not provide adequate protection from such irritation,which is further exasperated by the loose fit of the brace, or if theedges are flexible enough to be bent, they may dig into the skin evenmore. These edges can cause irritation to both the user, and to anyperson sharing the bed with the user.

Thus, there is a need for a dorsal splint that reduces the irritation toa user due to bulky and heavy braces, loose fitting braces, and braceshaving edges that can cause points of irritation. Further, there is aneed for a more comfortable, better fitting brace. Accordingly, a dorsalsplint is provided that has a low profile, is less bulky and islightweight, provides a good and comfortable fit, and solves otherproblems associated with previous splint designs.

SUMMARY

Exemplary embodiments of a dorsal splint are provided for treatingplantar fasciitis that are lightweight, low profile, provide a betterand more comfortable fit, and further reduce or eliminate irritation dueto edges causing points of irritation.

One embodiment of a dorsal splint includes a substantially rigid splintmember having upper, intermediate, and lower portions shaped andconfigured to be worn on the dorsal aspects of the lower leg, includingthe shin, dorsal surface of the ankle, or “dorsum,” and the dorsalsurface of the foot. A flexible edge overmold made from a compliant orflexible material is provided to encase at least an outer edge of theupper portion, and may be provided to encase the edges of theintermediate and lower portions in any desired configuration.

The flexible edge overmold reduces irritation caused by hard or sharpedges of the substantially rigid splint member and further allows thesubstantially rigid splint member to at least partially conform to thedorsal aspects of the lower leg. A flexible inner member may be utilizedin conjunction with the substantially rigid splint member in order toprovide a compliant interface between the dorsal splint and the dorsalaspects of the lower leg.

In an exemplary configuration, the flexible inner member is removablyattached to the upper, intermediate and lower portions and has first andsecond surfaces, and proximal and distal ends. The second surface of theflexible inner member defines at least one padded portion and the firstsurface of the flexible inner member has a hook receiving material. Apouch having a proximal surface including hook receiving material isformed along the first surface along the distal end of the flexibleinner member such that the lower portion is received within the pouch.The posterior surfaces of the intermediate and upper members carry hookmaterial for engaging the hook receiving material of the first surfaceof the flexible inner member. Suitable strap assemblies may be utilizedto retain the dorsal splint on the lower leg.

In a variation, the dorsal splint includes a strap in the form of a“figure 8,” such that a single strap defines a loop for tighteningaround the foot. The “figure 8” strap includes crossing over itself on aproximal surface of the intermediate portion of the substantially rigidsplint member, and forming another loop for tightening around the calf.The strap configuration allows for the pulling on one end of the strapto cause both loops to tighten simultaneously.

In another variation, the dorsal splint includes at least one slotformed in each of first and second wings of the upper portion forreceiving respective ends of a strap, wherein the flexible edge overmoldencompasses the slots.

In a further variation, the distal end of the flexible inner memberincludes an elastic fabric member secured to a first and second edgealong the distal end of the inner flexible member. A distal strap issecured to the distal surface of the elastic fabric member. A proximalstrap removably engages the slots in the upper portion and each of theproximal and distal straps may carry both hook material and hookreceiving material.

In an alternate configuration, the flexible inner member has first,intermediate, and second layers, wherein the first layer defines a hookreceiving material; the intermediate layer is a foam layer; and thesecond layer encases the intermediate foam layer.

In another variation of the dorsal splint, the flexible edge overmoldencases an outer edge of each of the upper, intermediate, and lowerportions. At least one slot is formed in first and second wings of theupper portion for receiving respective ends of a strap, and at least oneslot is formed in first and second sides of the lower portion forreceiving respective ends of a strap. The flexible edge overmold alsoencompasses the slots.

In a related variation, the lower portion also includes first and secondwings having slots formed therein for receiving respective ends of astrap. Similar to the previous variation, the flexible edge overmoldencompasses the slots.

In an alternate strap configuration, the distal strap includes a firstthickness in a middle portion, and a second thickness near first andsecond ends, where the first thickness is larger than the secondthickness. The straps are pulled from two sides and thus, the dorsalsplint will be properly positioned in the middle of the limb, as opposedto tilting to one side or the other when being pulled from a single sideonly and wrapped around the limb.

In another variation, an inflatable bladder is positioned between theproximal surface of the distal strap and the plantar surface of a foot.The bladder may be used to adjust the amount, or angle, of dorsiflexionprovided by the splint.

In another configuration, a pad is positioned between the proximalsurface of the distal strap and the plantar surface of a foot. The padmay be any suitable pad, such as a gel pad, and may provide therapeuticrelief, such as heating or cooling. Different sized pads may beinterchangeably provided to adjust the amount, or angle, of dorsiflexionprovided by the splint.

In an alternate configuration, each of the proximal and distal strapsincludes a first layer of flexible material having a first width and asecond layer of non-stretch material having a second width that is lessthan the first width. In this manner a more comfortably fitting,flexible edge strap is provided.

In another strap variation, each of the proximal and distal straps has afirst layer of flexible material having a first width and first andsecond strips of non-stretch material having a second width that is lessthan the first width. The first and second strips of non-stretchmaterial are positioned along first and second edges of the straps. Inthis manner the length of the strap is fixed, however the flexible layermay stretch and conform more closely to provide a more comfortable fit.Each of the proximal and distal straps may also have third and fourthstrips of non-stretch material positioned along respective first andsecond ends of the straps so that the ends of the straps may more easilypass through slots in the dorsal splint.

In another strap variation, each of the proximal and distal strapsincludes first, intermediate, and second layers, wherein the first andsecond layers are formed from hook receiving material and are positionedon respective sides of the intermediate layer, and the intermediatelayer is a foam layer to provide for a more comfortable, form fittingstrap.

In another embodiment, the dorsal splint includes an upper portionshaped and configured to engage the dorsal aspect of the leg. First andsecond living hinges are positioned along first and second sides of theupper portion from which first and second wing portions extend. Thelower portion also includes first and second living hinges positionedalong first and second sides of the lower portion from which first andsecond wing portions extend. The living hinges allow the wing portionsto flex about the hinges in order to better conform to the leg of theuser. When the dorsal splint is removed from the leg, the living hingescause the wing portions to spring back to their unflexed positions.

In another configuration, the dorsal splint has a flexible inner memberto which the overmold and the substantially rigid splint member areintegrally molded.

In an alternate configuration, the dorsal splint includes an upperportion and a lower portion. The upper and lower portions are rotatablyconnected via an intermediate portion connecting the upper and lowerportions in a rotatable manner.

In a further embodiment, the dorsal splint has a flexible member havingat least one longitudinal pocket for receiving a substantially rigidsplint member.

In another embodiment, the dorsal splint includes a substantially rigidsplint member. Compliant or flexible upper and lower wing portions areattached to the substantially rigid splint member at upper andintermediate or lower portions. Thus, the upper and lower wing portionsprovide a comfortable, conforming fit, while the substantially rigidsplint member defines the structural support for the lower leg.

In another embodiment, the dorsal splint comprises a flexible memberencasing first and second substantially rigid splint members. Eachsubstantially rigid splint member has an upper portion being shaped andconfigured to engage the dorsal aspect of the leg and an intermediateportion being shaped and configured to engage the dorsum. The flexiblemember further includes at least one pocket for receiving asubstantially rigid lower splint member being shaped and configured toengage the dorsal surface of the foot.

In another embodiment, the dorsal splint has a flexible member encasingfirst and second substantially rigid splint members. The flexible memberfurther defines at least one pocket located between the first and secondsplint members for receiving a substantially rigid third splint member.

The numerous advantages, features and functions of the variousembodiments of a dorsal splint will become readily apparent and betterunderstood in view of the following description and accompanyingdrawings. The following description is not intended to limit the scopeof the dorsal splint, but instead merely provides exemplary embodimentsfor ease of understanding.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side perspective view of an embodiment of a dorsal splint.

FIG. 1B is a rear view of the embodiment of a dorsal splint shown inFIG. 1A.

FIG. 1C is a front view of an inner flexible member for use with theembodiment of a dorsal splint shown in FIG. 1A.

FIG. 1D is a front view of the embodiment of a dorsal splint shown inFIG. 1A including the inner flexible member shown in FIG. 1C.

FIG. 1E is a front view of the embodiment of a dorsal splint, similar tothat shown in FIG. 1D, and including a proximal strap.

FIG. 2 is a perspective view of a dorsal splint according to anotherembodiment.

FIG. 2A is a perspective view of a dorsal splint according to analternate configuration.

FIGS. 3A-D are various views of embodiments of a “figure 8” strap in usewith an embodiment of a dorsal night splint.

FIGS. 4A-E are various perspective, side, and rear views of anotherembodiment of a dorsal splint.

FIG. 5 is a side view of another embodiment of a dorsal night splint.

FIGS. 6A-B are various front views of another embodiment of a dorsalnight splint.

FIG. 7 is a front perspective view of another embodiment of a dorsalnight splint.

FIGS. 8A-C are various front perspective views of another embodiment ofa dorsal night splint.

FIG. 9 is a bottom perspective view of an embodiment of a strap for usewith various embodiments of a dorsal splint.

FIGS. 10A-B are various perspective and front views of anotherembodiment of a dorsal splint.

FIG. 11 is a front perspective view of another embodiment of a dorsalsplint.

FIG. 12 is a front view of another embodiment of a dorsal splint.

FIGS. 13A-C are various front and side perspective views of anotherembodiment of a dorsal splint.

FIG. 14 is a bottom perspective view of another embodiment of a dorsalsplint.

FIG. 15 is a bottom perspective view of another embodiment of a dorsalsplint.

FIG. 16 is a bottom perspective view of another embodiment of a dorsalsplint.

FIGS. 17A-C are various views of another embodiment of a dorsal splintand an associated strap.

FIG. 18 is a side view of an embodiment of a strap for use with variousembodiments of a dorsal splint.

FIG. 19 is a bottom perspective view of an embodiment of a strap for usewith various embodiments of a dorsal splint.

FIGS. 20A-C are various views of an alternate strap configuration foruse with various embodiments of a dorsal splint.

FIG. 21A is a perspective view of another embodiment of a splint member.

FIG. 21B is sectional view taken along line XXIB-XXIB from FIG. 21A.

FIG. 21C is a posterior view of the embodiment shown in FIG. 21A.

FIG. 21D is a schematic view showing different shape configurations ofFIG. 21A.

FIG. 22A is an elevational view showing another embodiment of a splintmember having a strapping system.

FIG. 22B is a plan view showing the embodiment of FIG. 22A.

FIG. 22C is a plan view showing the embodiment of FIG. 22A in an openconfiguration.

FIG. 22D is a detailed schematic view showing the toe portion of FIG.22C in an open configuration.

In the various figures, similar elements are provided with similarreference numbers. It should be noted that the drawing figures are notnecessarily drawn to scale, but instead are drawn to provide a betterunderstanding of the components thereof, and are not intended to belimiting in scope, but rather provide exemplary illustrations.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A. Environment and Context of the Various Embodiments

The dorsal splint of this disclosure is designed for use by patientswhile sleeping at night. Of course, the dorsal splint is not limited tobeing worn at night, but may be worn at any suitable time. For example,any time that a user is sitting down, or otherwise is placing nopressure on the foot, the dorsal splint may be worn.

The dorsal splint is configured and arranged to be worn on either one ofthe left or right feet, ankles, and lower legs. Accordingly, thedescription will refrain from describing the dorsal splint with respectto left and right sides, or even lateral and medial sides, since asingle dorsal splint may be worn on either the right or left foot. Thedorsal splint is to be worn against the dorsal, or top, surfaces of thefoot, ankle, and the foreleg, or shin. Any suitable retention mechanismmay be used to retain the dorsal splint in proper position on the user.

The dorsal splint is configured to place the foot in dorsiflexion whileit is being used by a patient. Thus, the plantar fascia is maintained ina dorsi-flexed position in circumstances where the foot might otherwisenaturally tend towards plantarflexion. Accordingly, pain and tearing ofthe plantar fascia are avoided in situations where the shock of placingthe foot in dorsiflexion after prolonged periods of plantarflexion, suchas while standing up after a night of sleeping, would otherwise occur.

While not solely limited to use during sleeping, the majority of dorsalsplints are worn to bed during the night. Since dorsal splints must besubstantially rigid in order to maintain the foot in dorsiflexion, theuse of a dorsal splint for prolonged periods of time, for example aneight hour sleeping period, can cause discomfort to the wearer.Additionally, a sleeping partner of the user may also have contact withthe dorsal splint, and may also suffer discomfort from rigid surfacesand edges.

A number of embodiments of a dorsal splint are disclosed herein toprovide an improved dorsal splint that alleviates or eliminates theabove described, and other, shortcomings of the previous splints fortreating plantar fascia. These embodiments include improvements in thestructure of a dorsal splint and some of the different types ofretention mechanisms that may used therewith.

For further ease of understanding the dorsal splint as disclosed herein,a description of a few terms is necessary. As previously stated the term“dorsal” has its ordinary meaning and as used herein refers to the topsurfaces of the foot, ankle and foreleg or shin. As used herein, theterm “plantar” has its ordinary meaning and refers to a bottom surface,such as the bottom of a foot. As used herein, the term “proximal” hasits ordinary meaning and refers to a location that is closer to theheart than another location. Likewise, the term “distal” has itsordinary meaning and refers to a location that is further from the heartthan another location. The term “posterior” also has its ordinarymeaning and refers to a location that is behind or to the rear ofanother location. Lastly, the term “anterior” has its ordinary meaningand refers to a location that is ahead of or to the front of anotherlocation.

B. Detailed Description of Various Embodiments of a Dorsal Splint

One embodiment of a substantially rigid splint member 110 of a dorsalsplint 100 is shown in FIG. 1A. The substantially rigid splint member110 is shown in a stand-alone manner for ease of illustration.Additionally, the substantially rigid splint member 110 illustrated inFIG. 1A may be used in any number of configurations and embodimentsutilizing different padding or retention mechanisms. In order to providea more comfortable fit, the splint 100 has a flexible edge overmold 138and living hinges 136 to reduce irritation points and allow the splint100 to better conform to the user's limb.

Accordingly, the substantially rigid splint member 110 comprises threeportions, an upper portion 112, an intermediate portion 118, and a lowerportion 124. Each portion is shaped and configured to engage arespective portion of the wearer's body. For example, the upperposterior surface 116 is generally concave in shape to accommodate thefore leg, or shin. The shape of the concavity may be uniform ornon-uniform along the posterior surface 116. In order to provide a lowprofile dorsal splint, the upper anterior surface 114 may have acontoured shape to match the shape of the upper posterior surface 116.The upper portion 112 may have any suitable thickness in order toprovide the appropriate rigidity and support to the dorsal splint 100.The thickness may be uniform or non-uniform across the width, and alongthe length of the upper portion 112.

The upper portion 112 further has anterior 114 and posterior 116surfaces shaped and configured to engage the dorsal aspect of the leg.The upper portion 112 further includes first and second wing portions130 extending respectively from first and second sides of the upperportion 112 in order to extend the width of the upper portion 112 sothat it may wrap around the dorsal surface of the foreleg.

The intermediate portion 118 is integrally formed with the upper portion112 and includes anterior 120 and posterior 122 surfaces shaped andconfigured to engage the dorsum. As an alternative, the intermediateportion 118 may be formed as a separate piece from the upper portion112. The distinct pieces may be connected to each other in any suitablemanner, such as by welding or adhesives.

The intermediate portion 118 is shaped and configured to engage thedorsal aspect of the user's ankle. Accordingly, like the upper portion112, the posterior surface 122 of the intermediate portion 118 has asubstantially concave shape to accommodate the user's ankle. Similarlyto the upper portion 112, the shape of the concavity may be uniform ornon-uniform.

The width of the intermediate portion 118 may vary along its length inorder to provide an appropriate curvature to accommodate the variousprotrusions of the ankle joint. The thickness of the intermediateportion 118 may also be uniform or non-uniform.

The proximal end of the intermediate portion 118 is merged with thedistal end up the upper portion 112 and provides a smooth transitionsuch that a point of irritation is not created at the juncture. Ofcourse, if the intermediate 118 and upper portions 112 are separatelyformed and joined together, any appropriate surface treatment, such assanding, grinding, or polishing, may be utilized to provide a smoothtransition.

The lower portion 124 is integrally formed with the intermediate portion118 in order to form a single substantially rigid splint member 110.Proximal 126 and distal 128 surfaces are provided on the lower portion124. As an alternative, the lower portion 124 may be formed as aseparate piece from the intermediate portion 118. The distinct piecesmay be connected to each other in any suitable manner, such as bywelding or adhesives.

The lower portion 124 is shaped and configured to engage the dorsalaspect of the user's foot. Thus, the distal surface 128 of the lowerportion 124 has a substantially concave shape. A flared distal endportion is provided to avoid rigid corners that would dig into the fleshof the dorsal surface of the user's foot. As with the upper 112 andintermediate 118 portions, the concavity and thickness of the lowerportion 124 may be uniform or non-uniform.

As shown in FIG. 1A, slots 134 for straps are also provided along eitheredge of the lower portion 124. The slots 134 may have any suitablelength in order to accommodate straps of different sizes. Such slots mayalso be used to reduce the weight of the substantially rigid splintmember 110, even if a strap is not used directly with the slots 134 ofthe lower portion 124. Of course, if a strap is not to be used directlywith slots in the lower portion 124, the slots 134 in the lower portion124 may not be provided. Whether or not slots 134 are used, the strapsare pulled from two sides and thus, the dorsal splint 100 will beproperly positioned in the middle of the limb, as opposed to tilting toone side or the other when being pulled from a single side only andwrapped around the limb.

In a similar fashion as discussed above, the proximal end of the lowerportion 124 is merged with the distal end of the intermediate portion118 in order to provide a smooth transition between the two portions.

The combination of the three portions serves to position a user's foot,ankle, and lower leg in a dorsiflexion position. The angle ofdorsiflexion may be fixed by the relationship of the three members.Exemplary angles of dorsiflexion may be in the range of 80° to 90°. Inparticular, a range of 85° to 90° provides a suitable range ofdorsiflexion.

The substantially rigid splint member 110 may be formed from anysuitable material, for example any appropriate thermoplastic orthermosetting polymer, carbon, carbon fiber epoxy composite, plastic,fiber reinforced plastic, molded chopped fibers, laminates, metal or anyother suitable material. Exemplary materials include, but are notlimited to, nylons, glass filled nylon, polypropylenes, vinyls,polyvinyl chlorides, high density polyethylene, epoxies, urethanes, andpolyesters. The substantially rigid splint member 110 may be formed inany suitable manner, for example injection molding, casting, or curing.

As shown in FIGS. 1A and 1B, “living hinges” 136 are provided in theupper portion 112 between a main a section of the upper portion 112 andthe upper wing portions 130 in order to provide flexibility to the wingportions 130 so that the splint 100 may better conform to the user'slimb. The living hinge 136 is a thin section of material between themain section of the upper portion 112 and the upper wing portion 130.The living hinge 136 has a thickness that is less than the thickness ofthe rest of the upper portion 112 or the upper wing portions 130. Sincethe living hinge 136 has a smaller thickness than the upper portion 112or the upper wing portions 130, the wing portions 130 and the upperportion 112 are able to flex with respect to each other around theliving hinge 136.

The wing portions 130 and the upper portion 112 flex to conform to theuser's lower leg via a strap. Thus, a better fit is accomplished betweenthe dorsal splint and the user's leg. When the strap is removed, thewing portions 130 return to their unflexed position due to the action ofthe living hinges 136 in a manner that will be understood by the skilledartisan.

The specific construction of the living hinge 136 is dependent upon thedesired amount of flexing, and the direction of flexing. The actualthickness and shape of the living hinge 136 is dependent upon thethickness of the upper portion 112 and upper wing portions 130. Theliving hinge 136 may therefore be formed in any suitable shape, size andorientation, in order to provide the desired flexing characteristics.

For example, the living hinge 136 may be provided by a recessed line orgroove along the posterior surface 116 of the upper portion 112, and aprotruding line or a recessed line or groove along the anterior surface114 of the upper portion 112. The length of the living hinge 136 mayextend substantially along the entire upper portion 112 commensurate inlength with the upper wing portions 130. Alternatively, the length ofthe living hinge 136 may have any suitable length. The actual process offorming the living hinges 136 will be understood by a skilled artisan.

When the dorsal splint 100 is in place on the user's leg, the upperportion 112 is retained in position against the leg, and the upper wingportions 130 are able to flex in order to more closely conform to theuser's leg. In this manner, the dorsal splint 100 provides a better fitwith the user's leg, and enables a more comfortable fit since the dorsalsplint 100 more closely conforms to the shape of the user's leg. Theliving hinges 136 also aid in preventing the dorsal splint 100 fromsliding off of the patient's limb, since the extended upper wingportions 130 that (compared to a single rigid piece) to better conformto the shape of the leg when there is ankle movement.

As illustrated in FIG. 1A, a flexible edge overmold 138 is provided forencasing an outer edge of at least the upper portion 112. The overmold138 shown in FIG. 1A encases an outer edge of both the upper portion 112and the intermediate portion 118. The flexible edge overmold 138 may beformed from any suitable material, such as a flexible plastic. Exemplarymaterials include thermoset polymers, such as solid polyurethane, orthermoplastic elastomers.

In order to provide a low profile brace, the thickness of the overmold138 may be the same as or smaller than the upper portion 112 or anyother portion that the overmold 138 encases the edge of The width of theovermold 138 may be any suitable width so as to provide a compliantinterface between the substantially rigid splint member 110 and theuser's skin.

In alternative embodiments, such as illustrated in FIG. 1A, slots 134for receiving straps are provided in the wing portions 130 of the upperportion 112, and along the edges of the lower portion 124. As shown inFIG. 1A, the overmold 138 encompasses the slots 134 in the wing portions130 of the upper portion 112. Lines of greater thickness may be providedcoinciding with the living hinges 136 as a visual reference of theliving hinges, or as an aesthetic element. These lines may also beprovided in order to prevent cracks from forming in the overmold 138.

The overmold 138 may be formed in situ by injection molding, or bycuring in place. In order to aid with retaining the overmold 138 inplace, the edge which it encases may have an irregular shape, such as agrooved edge or protruding edge, to provide the material of the overmold138 a larger surface area for adhesion. Of course, the encompassing ofthe slots 134 by the overmold 138 also provides a larger surface areafor adhesion between the overmold 138 and the portion to which it isconnected.

The overmold 138 provides a flexible interface between the rigid edgesof the substantially rigid splint member 110 and the user's body. Thus,irritation due to the hard and sometimes sharp edges is reduced oreliminated. Accordingly, the dorsal splint 100 provides a morecomfortable fit for the prolonged use during sleeping for both the userand any person sharing the same bed as the user. This feature is animprovement over conventional dorsal splints that do not provideadequate protection from the rigid, and sometimes sharp, edges of thedorsal splints.

As shown in FIG. 1B, the groove or channel 137 defining the livinghinges 136 is provided along the posterior surface 116 of the uppermember 112. Further, the living hinge 136 defines a recess 139 formedbetween the wings 134 so as to facilitate bending of the wings 134relative to the upper portion 112. According to this embodiment, theovermold 138 only partially encompasses the slots 134 on the posteriorsurface 116 of the upper member 112, in order to keep the recess orgroove of the living hinge 136 free of material so that the upper wingportions 130 may more freely flex. This configuration may be used witheach embodiment described. Alternatively, although less desirable, theovermold 138 may partially encompass the groove or channel.

As shown in FIG. 1C, fastening mechanisms, such as patches of hookmaterial 140, are provided. The patches are positioned on the posteriorsurfaces 116, 122 of the upper 112 and intermediate 118 portions to aidwith removably retaining a flexible inner member 142 against theposterior surfaces 116, 122 of the upper 112 and intermediate 118portions, as will be more fully discussed below. Patches 140 may be ofany suitable size and may be attached to the posterior surfaces 116, 122of the upper 112 and intermediate 118 portions in any suitable manner,such as by adhesion.

Alternatively, patches 140 of hook material may be integrally injectionmolded with the substantially rigid splint member 110. Also, the patches140 may be of hook receiving material. Further yet, the patches 140 maycover substantially the entire posterior surfaces 116, 122 of the upper112 and intermediate 118 portions. It will be understood that, anysuitable fastening mechanism, such as snap fasteners, may be provided inplace of the patches of hook material 140.

As shown in FIG. 1C, the flexible inner member 142 has substantially thesame shape as the substantially rigid splint member 110. The flexibleinner member 142 acts as a compliant interface between a user's leg,foot, and ankle and the substantially rigid splint member 110.Accordingly, to aid with the reduction of irritation caused by thesubstantially rigid splint member 110, the flexible inner member 142 maybe slightly larger than the substantially rigid splint member 110.

As illustrated in FIGS. 1C and 1D, the flexible inner member 142 hasfirst 144 and second surfaces 146, and proximal 148 and distal 150 ends.The first surface 144 may carry or be made from hook receiving material.Alternatively, the first surface 144 may carry or be made from hookmaterial. The hook receiving material may be broken or unbroken loopmaterial formed by example from nylon. In this manner the first surface144 is selectively removably fixed to the posterior surfaces 116, 122 ofthe upper 112 and intermediate 118 portions.

A pouch 154 is provided on the first surface 144 along a portion of thedistal end 150 of the flexible inner member 142 for receiving at least aportion of the lower portion 124. The pouch 154 may be formed from anysuitable material and may define a proximal surface 156 that carries oris made from hook receiving material 158 for a purpose to be describedbelow. Of course, any suitable fastening material or mechanism, such ashook material or snap fasteners may be provided. In an alternativeconfiguration, the flexible inner member 142 does not include the pouch154, but instead is retained on the dorsal splint 100 via at least oneadditional patch of hook material 140 that is positioned on the distalsurface of the lower portion 124 in the same manner as discussed above.

In use, the lower portion 124 of the substantially rigid splint member110 is received within the pouch 154. The flared end portions of thelower portion 124 also help to engage the inner portions of the pouch154 to assist with maintaining the lower portion 124 within the pouch154. The first surface of the flexible inner member 142 is thenremovably fastened to the posterior surfaces 116, 122 of the upper 112and intermediate 118 portions. Thus the flexible inner member 142 isretained on the substantially rigid splint member 110 so that the dorsalsplint 100 may be placed upon the leg, ankle, and foot of the wearer. Asan alternative to the pouch 154, further hook and hook receivingmaterials, or any other suitable fastening mechanism, such as snapfasteners, may be provided. Further, the flexible inner member 142 maybe non-removably connected to the substantially rigid splint member 110by, for example, an adhesive.

The second surface 146 of the flexible inner member 142 includes ordefines at least one padding member 152. A plurality of padding members152 of varying thickness may be provided in any suitable pattern alongthe second surface 146. For example, a thicker padded portion may beprovided in the area of the intermediate portion in order to protect thebony protuberance of the dorsum. Alternatively, thicker padded portionsmay also be used to increase the angle of dorsiflexion. The padding maybe a thermoform pad having a pattern that provides a “formfit.” This maybe accomplished by utilizing various thicknesses throughout the pattern.The second surface 146 may be a soft covering that is not receptive toreceiving hook material. Of course, any suitable material or fabric willsuffice.

In order to aid with placing the dorsal splint 100 on the foot of theuser, an elastic fabric member 160 is provided. The elastic fabricmember 160 has proximal 166 and distal 168 surfaces, as well as first162 and second 164 ends connected to first and second edges along thedistal end 150 of the flexible inner member 142. The elastic fabricmember 160 thus forms a loop that the distal portion of the foot isplaced within in order to maintain the dorsal splint 100 in positionwhile allowing for further adjustment and tightening.

The ends 162, 164 of the elastic fabric member 160 may be connected tothe flexible inner member 142 in any suitable manner, such as by sewing,or by zipper closures. In an alternative embodiment, the elastic fabricmember 160 may form a continuous loop that has one surface secured tothe second surface 146 of the flexible inner member 142. Accordingly,the elastic fabric member 160 may be an elastic band, or an elasticstockinette, as will be recognized by a skilled artisan.

A distal strap 170 defining proximal 172 and distal 178 surfaces andfirst 182 and second 184 ends is connected to the distal surface 168 ofthe elastic fabric member 160. The connection may be such that the strap170 and elastic fabric member 160 are sewn together around a surface,along multiple lines, or adhesively or otherwise connected.

As best seen in FIGS. 1D, 1E, and 19, the strap 170 includes first 174,intermediate 176, and second 180 layers. The intermediate layer 176 maybe an open or closed cell, compressed or thermoformed foam material.Suitable materials include, but are not limited to, polyurethane foams.Thus a strap 170 is provided that includes some cushioning, such thatthe strap will not dig into the flesh of the user and thus will notcause pain and discomfort. The flexible inner member 142 may be formedin a similar tri-layer manner with the padding 152 being formed in thesame manner as the intermediate layer 176 of the strap 170.

The first 174 and second 180 layers define the proximal 172 and distal178 surfaces. The proximal 172 and distal 178 surfaces may both carry orbe composed of hook receiving material. Patches of hook material 140 mayalso be received along the first 182 and second 184 ends of the strap170. Of course, as previously discussed, the location of the hookmaterial and the hook receiving material may be interchanged, and otherfastening mechanisms, such as buckles or snap fasteners, may beprovided.

Once the dorsal splint 100 is located in position on the foot via theelastic fabric member 160, the first 182 and second 184 ends of thestrap 170 are folded up and over so that the patches of hook material140 engage the hook receiving material 158 of the proximal surface 156of the pouch 154, or the hook receiving material of the strap surfaces178. In this manner the lower portion 124 are tightened in positionalong the dorsal surface of the foot. During tightening, the straps arepulled from two sides and thus, the dorsal splint 100 will be properlypositioned in the middle of the limb, as opposed to tilting to one sideor the other when being pulled from a single side only and wrappedaround the limb.

A second, proximal strap 170, as shown in FIG. 1E, secures the upperportion 112 against the lower leg and shin of the user. The proximalstrap 170 may have the same construction as previously discussed withrespect to the distal strap 170. Each of the first and second ends ofthe proximal strap 170 are received in respective slots 134 in the upperwing portions 130. The proximal strap 170 extends from the slots 134between the posterior surface 116 of the upper member 112 and the firstsurface 144 of the flexible inner member 142 in order to encircle theuser's leg. The patches of hook material 140 on the proximal strap 170are connected directly to the hook receiving material of the surface ofthe strap 170 to tighten and fasten the proximal strap 170. Of course,any suitable alternate fastening mechanism may be utilized.

Given the above described construction, and in particular the livinghinge, overmold, and padded flexible member and straps, the dorsalsplint 100 provides an improved and more comfortable fit for both theuser and anyone sharing the bed of the user.

Of course, the dorsal splint 100 may be utilized in numerous variationsof the above described embodiment. For example, the substantially rigidsplint member 110 may be used without the flexible inner member 142, andmay instead have proximal and distal straps associated with the slots134 in the upper and lower portions.

As shown in FIG. 2, if the substantially rigid splint member 110 isutilized without the flexible inner member 142, it may be desirable toprovide the overmold 138 extending around the outer edge of the lowerportion 124, as well as the upper 112 and intermediate 118 portions. Aspreviously described, the overmold 138 may encompass the slots 134 inthe upper 112 and lower 124 portions.

In order to aid with placing the dorsal splint on the user's foot, anelastic band or stockinette may be connected directly to thesubstantially rigid splint member 110 in any suitable manner, such as byan adhesive. In the case that a stockinette is used, the stockinette mayextend along only a portion of the substantially rigid splint member110, for example, so as to engage only the plantar surface of the foot.Alternatively the stockinette may extend along the entire substantiallyrigid splint member 110 so as to engage the plantar surface of the foot,the heel, and the calf of a user.

An alternate configuration of a dorsal splint 100 is shown in FIG. 2A.The dorsal splint 100 has the same general configuration as previouslydiscussed. Upper wing portions 130 are delineated from the main dorsalsplint 100 via living hinges 136, in the exemplary manner that isdiscussed above. The wing portions 130 include slots 134 for receivingappropriate strap mechanisms therethrough, in a manner as discussedabove. A flexible edge overmold 138 is provided around the entireperiphery of the dorsal splint 100.

In order to attach a distal strap thereto, such as any strap disclosedherein, for example in FIGS. 19 and 20A-C, patches 140 of hook materialare provided on or embedded in the proximal surface 126 of the lowerportion 124 of the dorsal splint 100. Of course, the patches 140 mayalternatively be formed of hook receiving material. A skilled artisanwill recognize that at least a portion of any suitable strap will haveeither hook receiving or hook material therein respectivelycorresponding to the hook or hook receiving material of the patches 140for selective releasable engagement therewith.

The patches 140 provide an anchor point for any suitable distal strapthat is utilized with the dorsal splint 100. Any suitable strap may thusbe wrapped around the plantar surface of the foot and the ends thereofmay be anchored or engaged with the patches 140. Thus, there is no needfor slots in the lower portion 124 of the dorsal splint 100, and theflexible edge overmold 138 may extend around and encompass the entireperiphery of the dorsal splint 100.

In alternative embodiments, the substantially rigid splint member 110may include only the living hinges, and not the overmold, between thewing portions and the upper portion in order to provide the desiredamount of flexibility for an improved, closer fit. Alternatively, thesubstantially rigid splint member 110 may include only the overmold, andnot the living hinges, in order to provide a compliant interface betweenthe substantially rigid splint member 110 and the user's skin. Furtherembodiments are discussed in more detail below.

C. Detailed Description of an Embodiment of a Strap for a Dorsal Splint

As an alternative to utilizing both proximal and distal straps totighten the dorsal splint 100 to the user's body, a single strap 300 maybe utilized, as shown in FIGS. 3A-D.

As shown in FIG. 3A, a substantially rigid splint member 110, havingsimilar features as described above, such as a flexible edge overmoldand/or living hinges, is provided. Strap 300 is provided in the shape orform of a “figure 8.” More specifically, the strap 300 has first 302 andsecond 304 ends and first 312 and second 314 surfaces. The first end maybe fixed along the distal end of the dorsal splint 100, for examplealong the lower portion 124 or the intermediate portion 118.Alternatively, the first end 302 may be fixed to the first surface 312of the strap 300.

The second end 304 is wrapped around the substantially rigid splintmember 110 such that the second surface 314 of the strap contacts theproximal surfaces of each of the upper, intermediate, and lowerportions, and the first surface 312 of the strap 300 such that the strapcrosses over itself along the proximal surface of the intermediateportion and forms first 308 and second loops 310. Loop locks 306 may beprovided in order to keep the strap 300 in position with the loops 308,310 maintained.

In use, the user places the foot through both the loops 308, 310 so thefirst loop 308 will contract around the plantar surface of the foot andthe second loop 310 will contract around the calf of a user. The secondend 304 of the strap 300 is pulled to tighten both of the loops 308, 310simultaneously. The strap 300 may be provided with both hook materialand hook receiving material, for example a patch of hook material alongthe second end 304, such that once the strap 300 has been tightened itmay be locked in the tightened position.

Numerous configurations of the “figure 8” strap 300 may be utilized asexemplified in FIGS. 3C and 3D. For example, each loop portion 308, 310of the strap 300 may include an elastic or stretch portion 316 and anon-stretch portion 318. As shown in FIG. 3D, the elastic or stretchportion 316 and the non-stretch portion 318 may be formed as separatepieces that are attached only along the ends of one or the other of theelastic or stretch portion 316 and the non-stretch portion 318.

The “figure 8” strap may be utilized with any of the disclosedembodiments of a dorsal splint with the appropriate modifications.Specifically, a flexible inner member may be provided between the loopsof the strap and the substantially rigid splint member. Or, as describedin more detail below, inflatable or non-inflatable air bladders or gelpads may be used between the strap and the plantar surface of the foot.

D. Detailed Description of Another Embodiment of a Dorsal Splint

An embodiment of a dorsal splint 100 is shown in FIGS. 4A-E that issimilar to an embodiment discussed above with respect to FIGS. 1A-E, 2,and 2A. The dorsal splint as shown in FIGS. 4A-4E is constructed in asimilar manner and from the same materials as discussed above withrespect to the embodiments illustrated in FIGS. 1A-E, 2, and 2A.

In a modification from previous embodiments, as exemplified in FIGS.4A-4E, the overmold 138 encompasses upper wing portions 130, lower wingportions 132, and upper and lower slots 134. Thus, the lower portion 124provides an enlarged surface area for engaging the dorsal surface of thefoot. This configuration provides increased stability and increasedsupport to the dorsal aspect of the foot.

In another variation, while the dorsal splint 100 includes a flexibleinner member 142 similar in configuration to those previously discussed,there is no pouch member provided at the distal end of the flexibleinner member 142. Instead, the flexible inner member 142 is retained onthe substantially rigid splint member 110 via only hook and loop orother appropriate fastening mechanism, as discussed in detail above.

Again, as shown in FIGS. 4A and 4E, “living hinges” 136 are provided inthe upper portion 112 between a main a section of the upper portion 112and the upper wing portions 130 in a manner as described above.

As illustrated in FIG. 4E the flexible inner member 142 hassubstantially the same shape as the substantially rigid splint member110. The flexible inner member 142 may be constructed in substantiallythe same manner as discussed above, without the pouch portion on theproximal surface.

In use, the first surface of the flexible inner member 142 is removablyfastened to the posterior and distal surfaces 116, 122, 128 of the upper112, intermediate 118, and lower 124 portions, as shown in FIG. 4E. Thusthe flexible inner member 142 is retained on the substantially rigidsplint member 110 so that the dorsal splint 100 may be placed upon theleg, ankle, and foot of the wearer. As an alternative, the flexibleinner member 142 may be non-removably connected to the substantiallyrigid splint member 110 by, for example, an adhesive.

The second surface 146 of the flexible inner member 142 includes ordefines at least one padding member 152. A plurality of padding members152 of varying thickness may be provided in any suitable pattern alongthe second surface 146, as shown in FIG. 4D. For example, a thickerpadded portion may be provided in the area of the intermediate portionin order to protect the bony protuberance of the dorsum. Alternatively,thicker padded portions may also be used to increase the angle ofdorsiflexion. The padding may be a thermoform pad having a pattern thatprovides a “formfit.” This may be accomplished by utilizing variousthicknesses throughout the pattern. The second surface 146 may be a softcovering that is not receptive to receiving hook material. Of course,any suitable material or fabric will suffice.

Proximal and distal straps 170 are provided for engaging the slots 134in the upper wing portions 130 and in the lower portion 124. The straps170 have first 182 and second 184 ends respectively received in theslots 134 and have surfaces carrying or made from hook and/or hookreceiving material so that the straps 170 may be fastened ontothemselves, as shown in FIGS. 4A-D. Of course, any suitable fasteningmechanism, such as snap fasteners or buckles, may be used.

As shown, the straps 170 are positioned between the substantially rigidsplint member 110 and the flexible inner member 142, in order to preventcreating points of irritation. The straps may have a uniform ornon-uniform shape and size, for example the width may vary along thelength of the straps. The straps may be of the same layered constructionas previously discussed.

Given the above described construction, and in particular the livinghinge, overmold, and padded flexible member, the dorsal splint 100provides an improved and more comfortable fit for both the user andanyone sharing the bed of the user.

Of course, the dorsal splint 100 may be utilized in numerous variationsof the above described embodiment. For example, the substantially rigidsplint member 110 may be used without the flexible inner member 142, andmay instead have only the proximal and distal straps associated with theslots in the upper and lower portions.

In order to aid with placing the dorsal splint on the user's foot, anelastic band or stockinette may be connected directly to thesubstantially rigid splint member 110 in any suitable manner, such as byadhesive, or to the flexible inner member 142 in any suitable manner. Inthe case that a stockinette is used, the stockinette may extend alongonly a portion of the substantially rigid splint member 110, forexample, so as to engage only the plantar surface of the foot.Alternatively the stockinette may extend along the entire substantiallyrigid splint member 110 so as to engage the plantar surface of the foot,the heel, and the calf of a user.

In alternative embodiments, the substantially rigid splint member 110may include only the living hinges, and not the overmold, between thewing portions and the upper portion in order to provide the desiredamount of flexibility for an improved, closer fit. Alternatively, thesubstantially rigid splint member 110 may include only the overmold, andnot the living hinges, in order to provide a compliant interface betweenthe substantially rigid splint member 110 and the user's skin. Furtherembodiments are discussed in more detail below.

E. Detailed Description of a Collapsible Embodiment of a Dorsal Splint

A collapsible embodiment of a dorsal splint 500 is shown in FIG. 5.

In this embodiment, a flexible member 510 has a shape that roughlycorresponds, and may conform to, the dorsal aspects of a user's lowerleg, ankle and foot. The shape includes a generally rectangular shapewith a wider portion in the proximal area of the flexible member 510.The flexible member 510 may be formed from any suitable material, andmay include a plurality of layers. A suitable layered structure isdiscussed above with respect to straps 170. Accordingly, the flexiblemember may include layers of fabric and foam, including layers of hookreceiving material.

Amongst and/or within the layers is at least one pouch or pocket 512. Inthe exemplary, illustrated embodiment, three pouches 512 extendlongitudinally along the flexible member 510. Of course, any suitablenumber of pouches 512 may be used.

Respectively received within the three pouches 512 are threesubstantially rigid stays or splint members 514. Of course, the numberof substantially rigid stays or splint members 514 corresponds to thenumber of pouches or pockets 512. The substantially rigid splint members514 may be formed from any suitable material, for example anyappropriate thermoplastic or thermosetting polymer, carbon, carbon fiberepoxy composite, plastic, fiber reinforced plastic, molded choppedfibers, laminates, metal or any other suitable material. Exemplarymaterials include, but are not limited to, nylons, glass filled nylon,polypropylenes, vinyls, polyvinyl chlorides, high density polyethylene,epoxies, urethanes, and polyesters. The substantially rigid splintmembers 514 may be formed in any suitable manner, for example injectionmolding, casting, or curing.

The substantially rigid splint members 514 include an upper portionhaving anterior and posterior surfaces shaped and configured to engagethe dorsal aspect of the leg.

An intermediate portion is integrally formed with the upper portion andincludes anterior and posterior surfaces and is further shaped andconfigured to engage the dorsum. As an alternative, the intermediateportion may be formed as a separate piece from the upper portion. Thedistinct pieces may be connected to each other in any suitable manner,such as by welding or adhesives.

A lower portion is integrally formed with the intermediate portion inorder to form the substantially rigid splint members. Proximal anddistal surfaces are provided on the lower portion. As an alternative,the lower portion may be formed as a separate piece from theintermediate portion. The distinct pieces may be connected to each otherin any known suitable manner, such as by welding or adhesives.

Thus, the substantially rigid splint members 514 comprise threeportions, an upper portion, an intermediate portion, and a lowerportion. Each portion is shaped and configured to engage a respectiveportion of the wearer's body. For example, the upper posterior surfacemay be generally flat or concave in shape in order to accommodate thefore leg, or shin. The shape of a concavity may be uniform ornon-uniform along the posterior surface.

In order to provide a low profile dorsal splint, the upper anteriorsurface may have a flat or contoured shape to match the shape of theupper posterior surface. The upper portion may have any suitablethickness in order to provide the appropriate rigidity and support tothe dorsal splint. The thickness may be uniform or non-uniform acrossthe width, and along the length of the upper portion.

The intermediate portion is shaped and configured to engage the dorsalaspect of the user's ankle Accordingly, like the upper portion, theposterior surface of the intermediate portion may have a substantiallyflat or concave shape to accommodate the user's ankle Similarly to theupper portion, the shape of a concavity may be uniform or non-uniform.The thickness of the intermediate portion may also be uniform ornon-uniform. The proximal end of the intermediate portion is merged withthe distal end up the upper portion and provides a smooth transitionsuch that a point of irritation is not created at the juncture. Ofcourse, if the intermediate and upper portions are separately formed andjoined together, any appropriate surface treatment, such as sanding,grinding, or polishing, may be utilized to provide a smooth transition.

Similarly, the lower portion is shaped and configured to engage thedorsal aspect of the user's foot. Thus, the distal surface of the lowerportion may have a substantially flat or concave shape. As with theupper and intermediate portions, a concavity and thickness of the lowerportion may be uniform or non-uniform. In a similar fashion as discussedabove, the proximal end of the lower portion is merged with the distalend of the intermediate portion in order to provide a smooth transitionbetween the two portions.

The combination of the three portions serves to position a user's foot,ankle, and lower leg in a dorsiflexion position when used in combinationwith the flexible member 510. The angle of dorsiflexion may be fixed bythe relationship of the three members. Exemplary angles of dorsiflexionare in the range of 80° to 90°. In particular, a range of 85° to 90°provides a suitable range of dorsiflexion.

In use, the substantially rigid splint members 514 are received in thepockets or pouches 512 of the flexible member 510. The pouches orpockets 512 may have openings at either end, or along the length of thepouches, in order to receive the substantially rigid splint members 514.The openings may always be open, in order to allow the substantiallyrigid splint members 514 to be removably received therein. Or theopenings may be closed, in a known manner, once the substantially rigidsplint members 514 have been received therein. For example, the openingsmay be sewn shut. Alternatively, zipper, snap, or hook and loop closuresmay be provided to allow selective closure of the openings in order toallow selective removal of the substantially rigid splint members 514from the pockets or pouches 512. Thus, the brace is collapsible in orderto fit into a smaller package.

The pouches or pockets 512 and the substantially rigid splint members514 are slightly spaced from each other in order to allow the flexiblemember to more easily conform to the curved surfaces of the dorsalaspects of the user's lower leg, ankle, and foot, and to collapse into aflat configuration when not in use. Additionally, the wider portion ofthe proximal end of the flexible member 510 may have no rigid splints orstays in order to provide a more comfortable fit.

Straps of any suitable configuration, as discussed herein, are provided.For example, the flexible member 510 may be formed of softgood, andstraps may be sewn to the flexible member 510 at one end. The straps maycarry hook material at the other end in order to be fixed directly tothe flexible member 510 or to the straps themselves. Alternatively, theflexible member 510 may include slotted loops for receiving ends ofstraps, in a manner previously discussed.

Further embodiments of a dorsal splint are discussed in more detailbelow.

F. Detailed Description of an Embodiment of a Hybrid Dorsal Splint

An embodiment of a hybrid dorsal splint 600 is shown in FIGS. 6A and 6B.

A substantially rigid splint member 602 may be constructed in a similarmanner and with similar materials as previously discussed with respectto various other embodiments. As described with respect to previousembodiments, the substantially rigid splint member 602 includes upper,intermediate, and lower portions having anterior and posterior/distalsurfaces shaped and configured to engage the dorsal aspects of the leg.

Thus, the substantially rigid splint member 602 comprises threeportions, an upper portion, an intermediate portion, and a lowerportion. Each portion is shaped and configured to engage a respectiveportion of the wearer's body. For example, the upper posterior surfacemay be generally flat or concave in shape to accommodate the leg, orshin.

The intermediate portion is shaped and configured to engage the dorsalaspect of the user's ankle Accordingly, like the upper portion, theposterior surface of the intermediate portion may have a substantiallyflat or concave shape to accommodate the user's ankle

Similarly, the lower portion is shaped and configured to engage thedorsal aspect of the user's foot. Thus, the distal surface of the lowerportion may have a substantially flat or concave shape.

Thus, the combination of the three portions serves to position a user'sfoot, ankle, and lower leg in a dorsiflexion position. The angle ofdorsiflexion may be fixed by the relationship of the three members.Exemplary angles of dorsiflexion are in the range of 80° to 90°. Inparticular, a range of 85° to 90° provides a suitable range ofdorsiflexion.

The “hybrid” aspect of this embodiment of a dorsal splint arises fromthe addition of flexible members 604, 608 to the substantially rigidsplint member 602 as an alternative to the flexible edge overmold ofprevious embodiments. The flexible members 604, 608 may be fixed to thesubstantially rigid splint member 602 to provide a comfortable and closefit between the dorsal splint 600 and the user's leg. A flexible innermember 614 may also be provided, similar to those previously discussed.

The flexible members 604, 608 may be positioned as upper andintermediate or lower flexible members. The upper and intermediate orlower flexible members 604, 608 may attached to the substantially rigidsplint member 602 in any suitable manner, either in a fixed or removablemanner. For example, fasteners, such as rivets, 612 are provided. Sincethese elements are riveted strategically on and along the curvature ofthe main shell of the substantially rigid splint member 602, the overalldorsal splint maintains rigidity when it is worn, even with the use ofthin flexible members 604, 608. Of course, any suitable fasteningsystem, such as adhesive or snap fasteners, may also be used.

The upper and intermediate or lower flexible members 604, 608 have awidth greater than the substantially rigid splint member 602 in order todefine flexible wing portions 606, 610. The flexible wing portions 606,610 allow the dorsal splint 600 to better conform to the user's body, inorder to provide a closer and more comfortable fit. The flexible members604, 608 also flex inwardly in order to fit into a smaller package.

The flexible members 604, 608 may be formed from any suitable material,for example a thermoset polymer, such as solid polyurethane. Of courseany suitable material, such as a thermoplastic elastomer, may be used.

As previously mentioned, in order to provide an even more comfortableand closer fit, a flexible inner member 614, such as any of thosepreviously discussed, is also provided. Further, any suitable strappingmechanism, such as those discussed above and below, may be provided inorder to retain the dorsal splint 600 in position on the user's body.

Further embodiments of a dorsal splint are discussed in more detailbelow.

G. Detailed Description of an Embodiment of an Integral Dorsal Splint

An embodiment of an integral dorsal splint 700 is shown in FIG. 7. Theintegral dorsal splint 700 includes a flexible member 710 and definessurfaces which act as an interface between the dorsal splint 700 and thedorsal aspects of the leg. A substantially rigid splint member 720having a flexible edge overmold 730 is integrally formed on the proximalsurfaces of the flexible member 710.

The substantially rigid splint member 720 may have a similarconfiguration as previously discussed. The flexible edge overmold 730encases an outer edge of at least the upper portion, and as shownencases an outer edge of both the upper portion and the intermediateportion. Of course, the overmold 730 may encase the outer edge of thelower portion as well.

Both the substantially rigid splint member 720 and the overmold 730 maybe formed by injection molding directly onto and integrally with theflexible member 710.

In order to provide an even closer and more comfortable fit, the dorsalsplint 700 utilizes the flexible member 710 to provide a compliantsurface interface between the dorsal splint 700 and the dorsal aspectsof the leg. The flexible member 710 may be softgood, or a sheet ofmaterial, such as a polypropylene knit material, a polyester knitmaterial, a nylon, or any other suitable slightly porous material toallow the materials of the rigid splint member 720 and the overmold 730to pass therethrough to be become integrated with the flexible member710.

As shown in FIG. 7, the substantially rigid splint member 720 and theovermold 730 are integrally formed with the flexible member 710 byinjection molding. The pores of the flexible member 710 allow theplastic or polymer material of the substantially rigid splint member 720and the overmold 730 to pass through the flexible member 710 and to bindthe flexible member 710 to the substantially rigid splint member 720 andthe overmold 730.

Thus the flexible member 710 provides a soft and compliant interfacebetween the surfaces of the substantially rigid splint member 720 andthe body of the user. This allows the dorsal splint 700 to more closelyconform to the user's body.

Proximal and distal straps 740 are provided to maintain the dorsalsplint 700 on the body of the user. The straps 740 may be sewn orotherwise attached to the flexible member 710, for example via slots andloops along the edges of the flexible member 710. Alternatively, straps740 may be riveted or otherwise fastened to the anterior and proximalsurfaces of the substantially rigid splint member 720. Straps 740 may beof any suitable type or construction, such as those discussed above andbelow.

The overmold 730 and flexible member 710 provide a flexible interfacebetween the rigid edges of the substantially rigid splint member 720 andthe user's body. Thus, irritation due to the hard and sometimes sharpedges is reduced or eliminated. Accordingly, the dorsal splint 700provides a more comfortable fit for the prolonged use during sleepingfor both the user and any person sharing the same bed as the user. Thesefeatures are an improvement over conventional dorsal splints that do notprovide adequate protection from the rigid, and sometimes sharp, edgesof the dorsal splints.

In alternative embodiments, living hinges, of the type described herein,may be provided to increase the flexibility of the wider portions of thedorsal splint 700 in order to allow greater conformance to the user'sbody. Further embodiments of a dorsal splint are discussed in moredetail below.

H. Detailed Description of an Embodiment of an Alterable Dorsal Splint

An embodiment of an alterable dorsal splint 800 is shown in FIGS. 8A-C.

The alterable dorsal splint 800 includes substantially rigid upper andlower splint members 810, 820.

The upper member 810 includes anterior and posterior surfaces and isshaped and configured to engage the dorsal aspect of the lower leg. Theupper member further includes first and second wing portions extendingrespectively from first and second sides of the upper portion. The upperposterior surface is generally concave in shape to accommodate the foreleg, or shin. The shape of the concavity may be uniform or non-uniformalong the posterior surface. In order to provide a low profile dorsalsplint, the upper anterior surface may have a contoured shape to matchthe shape of the upper posterior surface. The upper portion may have anysuitable thickness in order to provide the appropriate rigidity andsupport to the dorsal splint 800. The thickness may be uniform ornon-uniform across the width, and along the length of the upper portion.

The lower portion 820 is shaped and configured to engage the dorsalaspect of the user's foot. Thus, the distal surface of the lower portionhas a substantially concave shape. A flared distal end portion may beprovided to avoid rigid corners that would dig into the flesh of thedorsal surface of the user's foot. As with the upper portion, theconcavity and thickness of the lower portion may be uniform ornon-uniform.

An intermediate connector portion 830, such as a hinge or joint, isprovided between the upper 810 and lower 820 portions. The intermediateconnector portion 830 is formed to allow relative rotation between theupper 810 and lower 820 portions in order to reduce the overall size orlength of the dorsal splint 800 when the splint is not in use.

A flexible edge overmold or living hinges, as previously discussed, maybe provided for one or both of the upper 810 and lower 820 portions. Asuitable flexible inner member and/or suitable fastening and tighteningmechanisms, as discussed above and below, may also be provided.

As shown in FIG. 8A, a flip type hinge is provided as the intermediateconnector portion 830. This hinge type is common in mobile phones, andmay be referred to as a “flip phone” hinge. This hinge allows the upper810 and lower 820 portions to be opened and closed in a manner so thatwhen closed, the lower portion 820 lies against the upper portion 810.In this manner the overall length of the dorsal splint 800 is reducedwhen the splint is not in use.

The hinge may be provided with suitable locking mechanisms, as will berecognized by the skilled artisan, such as a spring biasing mechanism,in order to prevent the accidental movement of the upper 810 and lower820 portions with respect to each other.

In an alternate configuration, as shown in FIG. 8B, a ball joint swivelbearing connection is provided. This connection provides relativerotation between the upper 810 and lower 820 portions in three axes. Alocking mechanism may be provided to lock the upper 810 and lower 820portions from relative movement, as will be recognized by a skilledartisan. In this manner the angle of dorsiflexion may be adjusted. Alsothe dorsal splint 800 may be adjusted for different inherent angles ofabduction/adduction in user's feet. Of course, when the dorsal splint isnot in use the upper 810 and lower 820 portions may be rotated to lieagainst each other in order to reduce the overall size and length of thesplint.

In yet another alternate configuration, as shown in FIG. 8C, a singleaxis swivel connection is provided such that the upper 810 and lower 820portions may be rotated in substantially a plane to lie against oneanother. As previously discussed, this allows the overall size andlength of the dorsal splint 800 to be reduced.

The combination of the three portions serves to position a user's foot,ankle, and lower leg in a dorsiflexion position. The angle ofdorsiflexion may be fixed or altered by the relationship of the threemembers. Exemplary angles of dorsiflexion are in the range of 80° to90°. In particular, a range of 85° to 90° provides a suitable range ofdorsiflexion.

Further embodiments of a dorsal splint are discussed in more detailbelow.

I. Detailed Description of an Embodiment of a Strap for a Dorsal Splint

An embodiment of a flexible (or flex) edge strap 900 for use with adorsal splint is shown in FIG. 9.

The flex edge strap 900 is formed from two layered materials. The firstlayer of material 910 may be a thin layer of flexible material such asurethane foam or neoprene. The first layer of material 910 has ordefines a first width.

The second layer of material 920 may be layer of non-stretch material,such as woven nylon. The second layer 920 further includes hookreceiving material. The second layer 920 has a width that is less thanthe width of the first layer 910 of flexible material.

The two layers 910, 920 are connected together in any suitable manner,such as by sewing or adhesive. The second layer 920 may be centeredalong the first layer 910, or may be offset or aligned along an edge ofthe first layer 910. The second layer 920 may be provided along theentire length of the first layer 910, or only along selected portions ofthe first layer 910. In this manner the lengthwise stretch of the strapmay be controlled by the second, non-stretch layer 920.

When the second layer 920 is centered along the length of the firstlayer 910 the strap 900 becomes a flexible edge strap. The strap 900 istherefore able to conform to the anatomy of the user so as to reducepressure points. The width of the second, non-stretch layer 920 may bevaried to alter the amount of flex along the edges of the strap 900.

Hook material is provided along the ends of the strap 900 so that thestrap 900 may be closed against itself when the hook material engageswith the hook receiving material of the second, non-stretch layer 920.

A skilled artisan will recognize many suitable materials that may beused to form each of the layers of the strap 900. The strap 900 may beutilized in any of the above or below discussed embodiments of a dorsalsplint.

Further embodiments of a dorsal splint are discussed in more detailbelow.

J. Detailed Description of another Embodiment of a Collapsible DorsalSplint

Another embodiment of a collapsible dorsal splint 1000 is shown in FIGS.10A and 10B.

In the embodiment shown in FIGS. 10A and 10B, a flexible member 1030,includes first, second, third, and fourth pockets 1032, 1034, 1036,1038. The first and second pockets 1032, 1034 extend lengthwise alongeither the first and second sides of the flexible member 1030 from theproximal end towards the distal end, and are formed along a centerlineof the flexible member 1030. The pockets 1032, 1034 extend to the pointin the flexible member 1030 of the transition between the ankle engagingportion and the foot engaging portion. Alternatively, the pockets 1032,1034 may extend the entire length of the flexible member 1030. Ofcourse, more than two pockets may be utilized.

The flexible member 1030 having a shape and configuration to conform tothe dorsal surfaces of the lower leg, ankle, and foot is provided. Theflexible member 1030 may be made from any suitable materials, such assoftgood, foam covered with suitable fabrics, or any other suitablematerials. The flexible member 1030 is provided with at least one pocketor pouch along a first or second surface.

The pockets 1032, 1034 may be formed in any suitable manner, such as bylayers of fabric connected along the edges of one of the layers bythreads, adhesive, or in any other suitable manner. The pockets may eachhave an open end along the proximal end of the flexible member 1030.Alternatively, the openings may be along the distal end, or along eithersurface of the flexible member 1030. The open ends may be maintainedopen or closed off in a manner described below.

Substantially rigid first and second splint members 1010, 1020 areprovided to be received within the first and second pockets 1032, 1034.The splint members 1010, 1020 may have upper, intermediate, and lowerportions that are shaped and configured to engage the dorsal aspect ofthe lower leg, ankle, and at least a portion of the foot. Alternatively,the splint members 1010, 1020 may have upper, intermediate, and lowerportions that are shaped and configured to engage the dorsal aspect ofthe lower leg, ankle, and a substantial portion of the foot.

The substantially rigid splint members 1010, 1020 may be formed from anysuitable material, for example any appropriate thermoplastic orthermosetting polymer, carbon, carbon fiber epoxy composite, plastic,fiber reinforced plastic, molded chopped fibers, laminates, metal or anyother suitable material. Exemplary materials include, but are notlimited to, nylons, glass filled nylon, polypropylenes, vinyls,polyvinyl chlorides, high density polyethylene, epoxies, urethanes, andpolyesters. The substantially rigid splint members 1010, 1020 may beformed in any suitable manner, for example injection molding, casting,or curing.

Each substantially rigid splint member 1010, 1020 includes anterior andposterior surfaces that may have the desired amount of uniform ornon-uniform curvature in order to be complementary shaped to the user'slower leg, ankle and foot. A skilled artisan will recognize that thesplint members 1010, 1020 may have any suitable and desired shape. Forexample, the splint members 1010, 1020 may be wider at a proximal endand narrower at the distal end. The width may vary in a uniform ornon-uniform manner in order to provide a comfortable fit for the user.

The first and second splint members 1010, 1020 are either removably orfixedly received in the first and second pockets 1032, 1034. The splintmembers 1010, 1020 are slid into the pockets. If it is desired tomaintain the splint members 1010, 1020 fixedly in the pockets 1032,1034, the open ends may be closed or selectively closed by threads,adhesives, zipper closures, or any other suitable manner.

The flexible member 1030 also includes third and fourth pockets 1036,1038, which may be formed as discussed above. The third and fourthpockets 1036, 1038 extend from the distal end towards the proximal endof the flexible member 1030. The third and fourth pockets 1036, 1038 areshaped to extend along the first and second sides of the flexible member1030 and along the distal portions of the first and second pockets 1032,1034. The pockets 1036, 1038 include open ends at the distal ends.Alternatively, the open ends may be provided at the proximal ends oralong either surface of the flexible member 1030. They may be providedwith any suitable shape.

First and second substantially rigid removable stays (or splint members)1040, 1050, are provided for insertion into the third and fourth pockets1036, 1038. While the stays 1040, 1050 are described as removable, theymay also be fixed within the pockets as discussed above with respect tothe splint members 1010, 1020. The stays 1040, 1050 may be formed in thesame manner as the splint members 1010, 1020, and from any of thematerials listed above. The stays 1040, 1050 may be shaped andconfigured to engage the dorsal aspect of the user's foot, and at leasta portion of the dorsal aspect of the ankle

Straps 1060 of any suitable configuration are provided at least alongthe proximal and distal portions of the dorsal splint 1000. The straps1060 may include hook material and/or hook receiving material, or anyother suitable fasteners, such as buckles or snap fasteners.

The substantially rigid portions combined serve to position a user'sfoot, ankle, and lower leg in a dorsiflexion position. The angle ofdorsiflexion may be fixed by the relationship of the three members.Exemplary angles of dorsiflexion are in the range of 80° to 90°. Inparticular, a range of 85° to 90° provides a suitable range ofdorsiflexion.

The use of two splint members 1010, 1020 and stays (or splint members)1040, 1050 to essentially divide the dorsal splint 1000 in half, allowsthe dorsal splint 1000 to take a lower profile while not attached to auser, for ease of storage. This configuration further allows the dorsalsplint 1000 to better conform to the user's lower leg, ankle, and foot,by allowing the splint 1000 to flex around its centerline. Of course, ifthe splint members 1010, 1020 and stays 1040, 1050 are allowed to beremovable, the flexible member may be completely flattened andcollapsed, thus reducing the space required for storage. Thus, thedorsal splint 1000 is more suitable for travel, so a user may use thesplint every night, even while traveling.

K. Detailed Description of Another Embodiment of a Collapsible DorsalSplint

Another embodiment of a collapsible dorsal splint 1100 is shown in FIG.11.

The flexible member 1130 is provided with at least one pocket or pouchalong a first or second surface.

As shown in FIG. 11, a flexible member 1130 includes a single pocket orpouch 1132 that extends length-wise along the entire flexible member1130. The pocket may be open at a proximal end, or along the distal end,or along either surface of the flexible member 1130. First, second, andthird splint members 1110, 1120, 1122 are either removably or fixedlyreceived in pockets 1132. The splint members 1110, 1120, 1122 are slidinto the pockets. If it is desired to maintain the splint members 1110,1120, 1122 fixedly in the pocket 1032 the open ends may be closed orselectively closed by threads, adhesives, zipper closures, or in anyother suitable manner.

Substantially rigid first and second splint members 1110, 1120 areprovided to be received within the pockets 1032. The splint members1110, 1120 have upper, intermediate, and lower portions that are shapedand configured to engage the dorsal aspect of the lower leg, ankle, andat least a portion of the foot. Alternatively, the splint members 1110,1120 may have upper, intermediate, and lower portions that are shapedand configured to engage the dorsal aspect of the lower leg, ankle, anda substantial portion of the foot.

A third splint member 1122 is provided between the first and secondsplint members 1110, 1120. The third splint member 1122 may be rigid inthe manner of the other splint members, or alternatively, may be madefrom a flexible material, such as plastic. Suitable materials mayinclude thermoplastic elastomers, silicones, or urethanes.

The flexible member 1130 may be similar to the previously discussedflexible member. The flexible member 1130 has a shape and configurationto conform to the dorsal surfaces of the lower leg, ankle, and foot. Theflexible member 1130 may be made from any suitable materials, such assoftgood, foam covered with suitable fabrics, or any other suitablematerials.

The substantially rigid splint members 1110, 1120 may be formed from anysuitable material, for example any appropriate thermoplastic orthermosetting polymer, carbon, carbon fiber epoxy composite, plastic,fiber reinforced plastic, molded chopped fibers, laminates, metal or anyother suitable material. Exemplary materials include, but are notlimited to, nylons, glass filled nylon, polypropylenes, vinyls,polyvinyl chlorides, high density polyethylene, epoxies, urethanes, andpolyesters. The substantially rigid splint members 1110, 1120 may beformed in any suitable manner, for example injection molding, casting,or curing.

Each substantially rigid splint member 1110, 1120 includes anterior andposterior surfaces that have the desired amount of uniform ornon-uniform curvature in order to be complementary shaped to the user'slower leg, ankle and foot. A skilled artisan will recognize that thesplint members 1110, 1120 may have any suitable and desired size andshape. For example, the splint member 1110, 1120 may be wider at aproximal end and narrower at the distal end. The width may vary in auniform or non-uniform manner in order to provide a comfortable fit forthe user. Further, the thickness may also vary in any suitable manner.

Straps 1140 of any suitable configuration are provided at least at theproximal and distal portions of the dorsal splint 1000. The straps 1140may include hook material and/or hook receiving material, or any othersuitable fasteners, such as buckles or snap fasteners.

The substantially rigid portions combined serve to position a user'sfoot, ankle, and lower leg in a dorsiflexion position. The angle ofdorsiflexion may be fixed by the relationship of the three members.Exemplary angles of dorsiflexion are in the range of 80° to 90°. Inparticular, a range of 85° to 90° provides a suitable range ofdorsiflexion.

The use of two splint members 1110, 1120 connected by a third, flexible,splint member 1122 to essentially divide the dorsal splint 1100 in half,allows the dorsal splint 1100 to take a lower profile while not attachedto a user, for ease of storage and for reduced shelf space duringdisplay. This configuration further allows the dorsal splint 1100 tobetter conform to the user's lower leg, ankle, and foot, by allowing thesplint 1100 to flex around its centerline.

Of course, if the splint members 1110, 1120, 1122 are allowed to beremovable, the flexible member may be completely flattened andcollapsed, thus reducing the space required for storage. Thus, thedorsal splint 1100 is more suitable for travel, so a user may use thesplint every night, even while traveling. Additionally, the dorsalsplint 1100 may be collapsed and packaged for sale in a smallercontainer, and thus may save sale display and shelf space, such thatmore dorsal splints 1100 may be displayed in a defined amount of space.

L. Detailed Description of Another Embodiment of a Collapsible DorsalSplint

Another embodiment of a collapsible dorsal splint 1200 is shown in FIG.12.

A flexible member 1230, similar to the previously discussed flexiblemember, has a shape and configuration to conform to the dorsal surfacesof the lower leg, ankle, and foot is provided. The flexible member 1230may be made from any suitable materials, such as softgood, foam coveredwith suitable fabrics, or any other suitable materials. The flexiblemember 1230 may be provided with at least one pocket or pouch along afirst or second surface.

As shown in FIG. 12, the flexible member 1230 includes a plurality ofpockets or pouches 1240 that apportion the width and length along theentire flexible member 1230. The pockets may be open at proximal ends,along distal ends, or along either surface of the flexible member 1230.

Substantially rigid segmented splint members 1220 are provided to bereceived within the pockets 1240. The splint members 1220 have portionsthat are shaped and configured to engage portions of the dorsal aspectof the lower leg, ankle, and the foot.

The substantially rigid segmented splint members 1220 may be formed fromany suitable material, for example any appropriate thermoplastic orthermosetting polymer, carbon, carbon fiber epoxy composite, plastic,fiber reinforced plastic, molded chopped fibers, laminates, metal or anyother suitable material. Exemplary materials include, but are notlimited to, nylons, glass filled nylon, polypropylenes, vinyls,polyvinyl chlorides, high density polyethylene, epoxies, urethanes, andpolyesters. The substantially rigid splint members 1220 may be formed inany suitable manner, for example injection molding, casting, or curing.

Each substantially rigid splint member 1220 includes anterior andposterior surfaces that have the desired amount of uniform ornon-uniform curvature in order to be complementary shaped to theappropriate portion of the user's lower leg, ankle and foot. A skilledartisan will recognize that the splint members 1220 may have anysuitable and desired shape.

The splint members 1220 are either removably, or fixedly, received inpockets 1240. The splint members 1220 are inserted into the pockets. Ifit is desired to maintain the splint members 1220 fixedly in the pocket1240 the open ends may be closed or selectively closed by threads,adhesives, zipper closures, or any other suitable manner.

Straps of any suitable configuration are provided at least at theproximal and distal portions of the dorsal splint 1200. The straps mayinclude hook material and/or hook receiving material, or any othersuitable fasteners, such as buckles or snap fasteners.

The substantially rigid portions combined serve to position a user'sfoot, ankle, and lower leg in a dorsiflexion position. The angle ofdorsiflexion may be fixed by the relationship of the three members.Exemplary angles of dorsiflexion are in the range of 80° to 90°. Inparticular, a range of 85° to 90° provides a suitable range ofdorsiflexion.

The use of a plurality of splint members 1240, allows the dorsal splint1200 to take a collapsed lower profile while not attached to a user, forease of storage. This configuration further allows the dorsal splint1200 to better conform to the user's lower leg, ankle, and foot, byallowing the splint 1200 to flex around the user's lower leg, ankle, andfoot. Of course, if the splint members 1240 are allowed to be removable,or are appropriately shaped, the flexible member may be completelyflattened or nearly completely flattened, thus reducing the spacerequired for storage. Thus, the dorsal splint 1200 is more suitable fortravel, so a user may use the splint every night, even while traveling.

M. Detailed Description of Another Embodiment of a Collapsible DorsalSplint

Another embodiment of a collapsible dorsal splint 1300 is shown in FIGS.13A-C.

A flexible member 1330, similar to the previously discussed flexiblemember, has a shape and configuration to conform to the dorsal surfacesof the lower leg, ankle, and foot is provided. The flexible member 1330may be made from any suitable materials, such as softgood, foam coveredwith suitable fabrics, or any other suitable materials. The flexiblemember 1330 is provided with at least one pocket or pouch along a firstor second surface.

As shown in FIG. 13B, the flexible member 1330 includes a single pocketor pouch 1332 that extends length-wise along the flexible member 1330.The pocket may be open at a proximal end, or along the distal end, oralong either surface of the flexible member 1330.

Substantially rigid first and second splint members 1310, 1320 areprovided to be received within the pockets 1032. The splint members1310, 1320 have upper, intermediate, and lower portions that are shapedand configured to engage the dorsal aspect of the lower leg, ankle, andat least a portion of the foot. Alternatively, the splint members 1310,1320 may have upper, intermediate, and lower portions that are shapedand configured to engage the dorsal aspect of the lower leg, ankle, anda substantial portion of the foot.

The substantially rigid splint members 1310, 1320 may be formed from anysuitable material, for example any appropriate thermoplastic orthermosetting polymer, carbon, carbon fiber epoxy composite, plastic,fiber reinforced plastic, molded chopped fibers, laminates, metal or anyother suitable material. Exemplary materials include, but are notlimited to, nylons, glass filled nylon, polypropylenes, vinyls,polyvinyl chlorides, high density polyethylene, epoxies, urethanes, andpolyesters. The substantially rigid splint members 1310, 1320 may beformed in any suitable manner, for example injection molding, casting,or curing.

Each substantially rigid splint member 1310, 1320 includes anterior andposterior surfaces that have the desired amount of uniform ornon-uniform curvature in order to be complementary shaped to the user'slower leg, ankle and foot. A skilled artisan will recognize that thesplint members 1310, 1320 may have any suitable and desired shape. Forexample, the splint members 1310, 1320 may be wider at a proximal endand narrower at the distal end. The width may vary in a uniform ornon-uniform manner in order to provide a comfortable fit for the user.

The first and second splint members 1310, 1320 are either removably, orfixedly, received in the pocket 1332. The splint members 1310, 1320 maybe temporarily connected to each other along their length and then maybe slid into the pocket 1332. If it is desired to maintain the splintmembers 1310, 1320 fixedly in the pocket 1332 the open end may be closedor selectively closed by threads, adhesives, zipper closures, or anyother suitable manner.

Straps 1340 of any suitable configuration are provided at least at theproximal and distal portions of the dorsal splint 1300. The straps 1340may include hook material and/or hook receiving material, or any othersuitable fasteners, such as buckles or snap fasteners.

The substantially rigid portions combined serve to position a user'sfoot, ankle, and lower leg in a dorsiflexion position. The angle ofdorsiflexion may be fixed by the relationship of the three members.Exemplary angles of dorsiflexion are in the range of 80° to 90°. Inparticular, a range of 85° to 90° provides a suitable range ofdorsiflexion.

The use of two splint members 1310, 1320 to essentially divide thedorsal splint 1300 in half, allows the dorsal splint 1300 to take acollapsed or lower profile while not attached to a user, for ease ofstorage. This configuration further allows the dorsal splint 1300 tobetter conform to the user's lower leg, ankle, and foot, by allowing thesplint 1300 to flex around its centerline. Of course, if the splintmembers 1310, 1320 are allowed to be removable, the flexible member maybe completely collapsed or flattened, thus reducing the space requiredfor storage. Thus, the dorsal splint 1300 is more suitable for travel,so a user may use the splint every night, even while traveling.

In an alternative embodiment, first, second, and third substantiallyrigid splint members may be provided and three pockets may be providedwithin the flexible member. The first and second splint members may besewn in, or otherwise fixedly received within first and second pocketsin the flexible member. The third splint member may then be removablereceived within the third pocket, in a manner previously discussed.Thus, the dorsal splint may have a lower profile when not in use toreduce the amount of storage space required.

N. Detailed Description of Various Embodiments of a Dorsal Splint

Various embodiments of a dorsal splint 100 are illustrated in FIGS. 14,15, 16, and 17A-C. The dorsal splint 100 of these embodiments has thesame basic structure and configuration as discussed above with respectto the embodiments shown in FIGS. 1A-E, 2, 2A, and 4A-E.

As shown in FIG. 14, instead of a strap of hook and hook receivingmaterial, an elastic fabric strap 170 is provided. The strap may haveany suitable configuration to provide a comfort fit, such as anelongated opening along the portion of the strap that contacts theplantar surface of the foot.

As shown in FIG. 15, a pad or bladder 196 is provided between the strap170 and the plantar surface of the foot. Any suitable pad 196 may beused, such as a gel pad, for example silicone gel or any suitable gel.The gel pad 196 may be utilized to provide therapeutic benefits, such asheating or cooling. Alternatively, a bladder 196 may be used in place ofthe gel pad. The bladder may be closed and formed of materials that willexpand very little to define a single size. An inflatable or expandablebladder may also be used. The bladder may be filled with any suitablefluid, such as water or air, in order to define a particular size pad.Different size pads or bladders, or the expandable bladder, may beprovided to alter the amount of dorsiflexion provided by the dorsalsplint 100.

As shown in FIG. 16, the substantially rigid splint member 110 includeslower wing portions 132 along the edges of the lower portion 134 of thesubstantially rigid splint member 110. At least one slot 134 is providedin each of the lower wing portions 132 for receiving strap ends in amanner previously discussed. The lower wing portions 132 may be providedwith living hinges in a similar manner as discussed above. As alsodiscussed above, the overmold 138 encases an outer edge of the lowerportion 124 of the substantially rigid splint member 110 and furtherencompasses the slots 134 in the lower wing portions 132. Thisconfiguration provides the benefits, as discussed above, of a better andmore comfortable fit for the dorsal splint 100.

A distal strap 170 is provided for engaging the slots 134 in the lowerportion 124 of the substantially rigid splint member 110. In order toadjust the angle of dorsiflexion, a plurality of interchangeable strapsmay be provided having different thicknesses. For example, the portionof the strap 170 that contacts the plantar surface of the foot may havea first thickness, and the edges of the strap that engage the slots mayhave a second thickness that is less than the first thickness. A second,interchangeable strap may be provided having a third thickness in theportion of the strap that contacts the plantar surface of the foot,while having the same second thickness along the edges. The thirdthickness may be less than or greater than the first thickness and thesecond thickness along the edges may be less than the third thickness.In this manner, the dorsiflexion may be adjusted by the use of differentstraps.

An alternate embodiment of the lower wing portion 132 is shown in FIG.17A. In this embodiment, two slots 134 are provided in each of the lowerwing portions 132, for receiving the ends of a dual strap 190, as shownin FIGS. 17B and 17C. The dual strap 190 has first and second strapportions 192, 194 combined with a connecting portion 195. The first andsecond strap portions 192, 194 may be formed from an inelastic,non-stretch fabric, such as woven nylon. The first and second strapportions 192, 194 may each include hook and/or hook receiving materialat either end thereof

The connecting portion 195 may be formed from a somewhat flexible orstretchy material, such as a urethane foam, or neoprene, or any othersuitable material, in order to provide a comfortable fitting surface forthe plantar surface or to conform to the convex shape of the plantarsurface of the user's foot. The connecting portion 195 may be providedwith hook and/or hook receiving material so that the ends of the firstand second strap portions 192, 194 may be connected thereto.

Of course, the different features discussed herein may be utilized withany of the previously disclosed embodiments. Specifically, any of thestraps utilizing gel pads or bladders may be utilized with any dorsalsplint disclosed herein.

O. Detailed Description of Various Strap Embodiments for Use With aDorsal Splint

An embodiment of a hybrid strap 1800 for use with a dorsal splint isshown in FIG. 18.

The hybrid strap 1800 is formed from a layer of flexible material 1810which may be a thin layer of flexible material such as urethane foam orneoprene. The layer of flexible material 1810 has or defines a firstwidth, which may be uniform or non-uniform.

Strips 1820 of non-stretch material, such as woven nylon having widthsthat are less than the width of the layer of flexible material 1810 areprovide along the length of the layer of flexible material 1810. Thus,the length of the hybrid strap is fixed. In alternative configurations,the non-stretch material can be shorter than stretch material so it onlylimits the overall stretch of the strap. Also, the materials may havenon-linear shapes (half moon, etc.) in order to vary the strap stretchacross the width of the strap.

The strips 1820 and the layer of flexible material 1810 are connectedtogether in any suitable manner, such as by sewing or adhesive. Thestrips 1820 may aligned along the edges of the layer of flexiblematerial 1810, or offset from the edges. In this manner the lengthwisestretch of the strap is limited, and the length of the strap is fixed.

The width of the strap 1800 is varied by the flexibility of the layer offlexible material 1810. Thus a more comfortable strap is provided thatmaintains the splint in position on the foot or calf with a consistentstrength, due to the fixed strap length, is provided.

Hook and/or loop material is provided along the layer of flexiblematerial 1810. Fasteners of hook and/or loop material 1830 are providedalong the width at each end of the layer of flexible material 1810. Thefasteners may also be of non-stretch material, so that the ends of thestrap 1800 may be easily passed through slotted portions in the dorsalsplint.

The strap 1800 may be utilized in any of the embodiments of a dorsalsplint discussed herein.

An alternate configuration of a strap 170 is shown in FIG. 19, aspreviously mentioned. The strap 170 may be a thermoformed padding strap.The strap 170 includes foam 176, non-stretch unbroken loop material 174on one side, and stretch material 180 on the other side where a patternis formed. The thermoformed side 180 is positioned against the skin,thus providing cushioning. In this way, the strap 170 has a defined andlimited length; however, the cushioning of the foam 176 allowsconformity of the strap 170 against the foot. Holes may be strategicallyplaced (where the pad thickness is completely knocked down) on thethermoformed area to provide breathability.

A further embodiment of a distal strap assembly 2060 for use with adorsal splint 2000 is shown in FIGS. 20A-C. In this configuration, aflexible edge overmold 2038 extends around and encompasses the peripheryof the dorsal splint 2000. Slots 2034 in the lower portion of the dorsalsplint 2000 provide attachment points for straps 2070 of the strapassembly 2060.

The strap assembly 2060 also includes a distal bottom piece 2080 thathas a width W that is as large as the average male's foot for preventingMorton's neuroma, a noncancerous (benign) growth of nerve tissue thatcan develop in a nerve of the foot, often between the third and fourthtoes. The condition involves a thickening of the tissue around one ofthe digital nerves leading to the toes.

The distal bottom piece 2080 includes two outer layers 2082 of softmaterial that are secured to each other at least around two or threeedges in order to form a pocket or pouch 2086 therebetween. A cushion orfoam layer 2084 is also provided within the pouch 2086 towards theproximal outer layer 2082. The cushion layer 2084 is secured at itsedges to at least one of the outer layers 2082.

At least one substantially rigid stay or insert 2090 may be insertedinto the pouch 2086 in order to provide structural support to the distalbottom piece 2080 and the plantar surface of the foot, as shown in FIG.20B. The stay or insert 2090 may be made from any of the above mentionedmaterials. As shown in FIG. 20C in an alternate configuration, two staysor inserts 2090 are provided into the pouch 2086, which may separate thetwo stays or inserts 2090 via a seam 2092 that extends the length of thedistal bottom piece 2080. In a further variation, the insert 2090 may becut down the middle in order to reduce the size of the packagingrequired for the dorsal splint 2000.

Attachment points in the form of D-rings 2088 are provided along thesides of the distal bottom piece 2080 for engagement with the straps2070. As best seen in FIG. 20B, one end of each strap 2070 engages arespective slot 2034 in the dorsal splint 2000 and the straps 2070 passthrough a respective D-ring 2088. The other ends of the straps 2070 wraparound the proximal surface of the lower portion of the dorsal splint2000. The straps 2070 may thus engage each other to complete theattachment. Alternatively, patches of hook or hook receiving material,such as those shown in FIG. 2A may be provided on or embedded in theproximal surface of the lower portion of the dorsal splint 2000 so theother ends of the straps 2070 may be anchored thereto.

As previously mentioned, the insert piece 2090 can be removabledepending on the user's need. Alternatively, the insert piece 2090 orpieces may be retained in the pocket or pouch 2086 in a manner similarto those previously discussed.

P. Detailed Description of an Embodiment of a Dorsal Splint

In observing FIGS. 21A-21C, another embodiment of a splint member 2100is shown. According to this embodiment, the splint member 2100 includesmany of the features belonging to other embodiments described hereinincluding upper and lower portions 2123, 2125, a substantially rigidintermediate portion 2102 surrounded by an edge overmold 2104 and livinghinges 2108. These features may be similar to those described inconnection with the basic embodiment of FIGS. 1A-1E.

The splint member 2100, in a variation of other embodiments describedherein, includes an aluminum stay 2106 (depicted by dashed lines) whichis preferably embedded or encased within the intermediate portion 2102.The aluminum stay 2106 is preferably bendable at bend area 2118 alongwith the intermediate portion 2102 in order to custom-fit or modify thetherapeutic angle of the splint member 2100. However, when worn on aleg, the stay 2106 effectively retains its bent shape so as to maintainits shape and the shape of the intermediate portion 2102. It is onlywhen the splint member 2100 is not in use or being worn that one maymodify the shape of the splint member 2100.

As depicted in FIG. 21D, the splint member 2100, by way of the stay2106, may be bent from an original splint member shape 2128A to amodified splint member shape, as exemplified by 2128B. The splint member2100 generally bends at or around the bend area 2118, as shown in FIG.21A.

The intermediate portion 2102 defines a plurality of locating apertures2124 which reveal the location of the stay 2106 located within theintermediate portion 2102. The intermediate portion 2102 defines arecessed portion 2119 located around the bend area 2118 whichfacilitates and indicates the bending of the stay 2106. Other aperturesmay be located on the intermediate portion to further reveal the stay2106 and to reduce weight of the intermediate portion 2102.

The intermediate portion 2102 defines along its length an upper neck2103 and a lower neck 2105, and a bulbous width portion 2107. The upperand lower necks 2103, 2105 reduce the material of the width of theintermediate portion 2102 and minimize extension of the rigid splintmaterial over the foot and ankle. As a result of the upper and lowernecks 2103, 2105, the edge overmold 2104 defines flap portions 2109,2111 defined by larger portions of material defining the edge overmoldthereby providing greater cushioning along the foot and anklecorresponding to such flap portions.

The edge overmold therefore has sections of greater size, defined bylength, width or thickness, located along the length of the rigid splintmember. The overmold edge sections may be tailored in size according tolocations of the foot and ankle to provide increased of cushioning.

Additionally, the intermediate portion 2102 forms an opening 2110 whichcorresponds to an opening 2130 formed within the stay 2106. Thesecorresponding openings 2110, 2130 allow for one to identify if the stay2106 is properly aligned with the intermediate portion 2102. A recessedportion 2114 is located on the bulbous portion 2107 and surrounds theopening 2110, and allows for the location of a fastener material, suchas a loop fabric, to be inserted therein. The geometry of the bulbousportion 2107 provides a greater area to secure fastener material andcorresponding straps.

Turning to the posterior of the splint member 2100, while it ispreferable that the stay 2106 is embedded within the intermediateportion 2102, it is evident from FIGS. 21B and 21C that the stay 2106may slightly bulge along lines 2122 of the intermediate portion 2102.Further, cross-tabs 2120 may be molded or applied to the posterior sideof the intermediate portion 2102 for the location of a fastenermaterial, such as a hook fabric to be inserted therein.

Another feature of the embodiment of FIGS. 21A-21B is the provision ofventing through slots 2116, 2126. These slots 2116, 2126 areparticularly advantageous when strapping is provided with the splintmember 2100 so as to allow for adequate ventilation through the strapsand the splint member. The slots further reduce material of theintermediate portion, and may be combined with recesses 2112 so as tominimize the weight of the splint member. The slots or recesses may beprovided at a plurality of locations of the splint member and are notlimited to the arrangement shown herein. As for the holes 2116, theseare provided to locate and stabilize the stay 2106 in place during themolding process. The recesses 2112 may extend through the entirety ofthe splint member 2100 so as to allow for better breathability, as inthe slots 2116, 2126, may be provided to reduce weight of the splintmember 2100, or can be provided for ornamental purposes.

Q. Detailed Description of Another Strap System for Use With a DorsalSplint

FIGS. 22A-22D exemplify a strap system 2200 which may be used incombination with embodiments of splint members 2202 described herein.This strap system 2200 is provided to snugly secure the splint member2202 to the foot, ankle and calf portions of the wearer. Padding isprovided along with the strapping to more comfortably and stably connectthe splint member to the wearer.

The strap system 2200 includes an ankle portion 2204 and a toe andplantar portion 2206 which are connected by a bridge portion 2208. Acalf portion 2210 extends from the ankle portion 2204. An interiorpadding liner 2224 may be secured to the posterior surface of the splintmember 2202 so as to cushion the foot and leg when the strap system 2200tightens the splint member 2202 against the foot and leg. The interiorpadding may be of any type described herein, such as a thermoformedpadding having localized areas of different degrees of compressibilitycorresponding to different parts of the foot, ankle and leg, or acontinuous padding having generally uniform compressibility andconsistent thickness.

The ankle portion 2204 includes a heel stirrup 2222 which secures thestrap system 2200 to the heel and under the foot. The ankle portion 2204includes opposed straps 2225, 2226 that secure opposed ends of the ankleportion 2204 over the anterior surface of the splint member. The ankleportion 2204 also includes generally stretchable straps 2231, 2233connecting to the padding liner 2224 and the straps 2225, 2226. Thestretchable straps 2231, 2233 permit adjustment of the straps 2225, 2226to the splint member, and also further retain the splint member on theankle when the straps 2225, 2226 are adjusted.

The splint member may define a recessed portion, as in the recess 2114in FIG. 21A, which accommodates a hook and loop material and secures tocorresponding hook and loop material on the strap 2226. A strap locator2234 may be located on the splint member 2202 to retain the straps in aposition relative to the splint member 2202 (i.e., the splint member maybe formed from plastic upon which the straps may slide).

The calf portion 2210 includes opposed tabs 2215, 2216 securing to slots2230 which are formed on the splint member 2202. The tabs 2215, 2216 andlocations on the calf portion 2210 fasten to one another via fasteners,such as with corresponding hook and loop material.

The ankle portion 2204 connects to the toe portion 2206 via the bridgeportion 2208. The bridge portion 2208 may be formed from a stretchablematerial so as to accommodate movement of different portions of the legand foot and different foot sizes. Alternatively, the bridge portion2208 may be substantially non-stretchable so as to maintain the ankleand toe portions 2204, 2206 in close-relationship. The selection of thebridge portion material thus will depend on the activity of the wearerand the intended treatment served by the splint member and the strapsystem.

Turning to the toe portion 2206, this secures to the splint member 2202via a sleeve 2211 fitted to closely conform to the corresponding toeportion of the splint member 2202. An edging 2232 extending from thesleeve 2211 wraps about peripheral edge portions of the splint member2202 into portions corresponding to the ankle portion 2204 and calfportion 2210 of the strap system 2200. The interior side of the sleeve2211 forms part of the inner padding liner 2224 and the edging 2232likewise forms part of or connects to the interior padding liner 2224.The sleeve 2211 and the edging 2232 may be secured to the splint member2202 by suitable fasteners such as hook and loop material.

The toe portion 2206 includes an angled pull defined by stitching ordivider 2227 which joins two opposing ends 2221, 2223 of each ofcorresponding straps 2212, 2214. By pulling on the straps 2212, 2214 tojoin the straps to one another, the straps wrap around the prominentbony area of the foot (head of the metatarsal joints) comfortably fromopposite directions so as to conform to the toe region of the foot.Suitable fastener systems of types described herein and known to theskilled artisan may be used to secure the straps 2212, 2214 to oneanother.

The toe portion 2206 also includes a plantar pad 2228. This plantar pad2228 may be formed from a high density foam or rigid plastic sheetplaced along the plantar portion of the toe portion 2206 where themetatarsals will be when the splint member worn. Portions of the plantarpad 2229 may comprise island pads that have increased areas ofcompressibility or are distinguished from other areas on the basis ofsurface area or other geometry in order to accommodate the correspondingregion of the foot. As with similar embodiments described herein, theplantar pad is included to provide rigidity to avoid pressure points onthe heads of the metatarsal joints so as to prevent Morton's neuroma.

The toe portion 2206 further includes openings 2218 formed on bothstraps 2212, 2214 so as to provide pressure relief on the side of thefoot when the strap system 2200 is tightly secured to the leg and foot.This pressure relief on the side of the foot also assists in preventingMorton's neuroma.

Lastly, the toe portion 2206 includes a toe stopper 2220 connecting orsecurable to the front end of the sleeve 2211 and the inner paddingliner 2224. Further, the toe stopper 2220 provides a visual guide forproper application of the splint member to the foot. The splint memberis found to be more functional when the bottom end of the splint memberis placed close to the end of the foot. The toe stopper 2220 visuallyguides the wearer to maintain the toes from passing through orinadequately approaching the end of the splint member duringapplication. Additionally, the toe stopper 2220 is positioned tomaintain the angle of the flexion of the foot by maintaining bettercontact with the shell and foot.

The strapping system 2200 may be formed in the manner of any of theother strap embodiments described herein, and is not limited to thepadding and individual straps shown herein.

R. Conclusion

The disclosed embodiments of a dorsal splint and straps for use with adorsal splint provide great flexibility for dorsal splints having betterand more comfortable fit, improved ability to hold a functional angle ofthe foot in flexion for optimum therapeutic value, and for dorsalsplints that may have lower profiles for retail display, storage, andtraveling.

It is understood that the size of the dorsal splint and the componentsthereof can be adjusted so that different users having different sizedlegs, ankles, and feet may benefit from the present design.Specifically, the width, thickness and length of the splint member maybe varied to accommodate different sized users. Of course, many of theimprovements disclosed herein, such as the overmold and the livinghinge, allow a single size dorsal splint to comfortably fit a largernumber of different sized users.

Of course, it is to be understood that not necessarily all objects oradvantages may be achieved in accordance with any particular embodimentof the invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variousfeatures from different embodiments. In addition to the variationsdescribed herein, other known equivalents for each feature can be mixedand matched by one of ordinary skill in this art to construct a dorsalsplint in accordance with principles of the present invention.

Although this invention has been disclosed in the context of certainexemplary embodiments and examples, it therefore will be understood bythose skilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above.

The invention claimed is:
 1. An orthopedic device, comprising: a splintmember being substantially rigid and formed from a thermoplastic orthermosetting polymer, the splint member defining anterior and posteriorsurfaces, the splint member having an original shape wherein the splintmember defines along a length of the splint member an upper portion, anintermediate portion and a lower portion, and in the original shape theposterior surface of the splint member has a concave shape along thelength of the splint member and at least in the intermediate and upperportions, and the splint member has rigid edges which are hard; an edgeovermold being flexible and integrally secured along at least a portionof the rigid edges of the splint member, the edge overmold extendingoutwardly from the periphery of the splint member and having greaterflexibility than the splint member; a stay being formed from a bendablealuminum metal embedded in the splint member between the anterior andposterior surfaces and within the intermediate portion of the splintmember, the stay arranged to maintain a shape when the orthopedic deviceis worn by a wearer, and wherein the stay is bendable to place thesplint member into a modified shape different from the original shape;wherein the splint member and the stay form a bend area located onlywithin the intermediate portion of the splint member such that the stayis bendable at the bend area in order to custom-fit or modify atherapeutic angle of the splint member within the intermediate portionby arranging the upper and lower portions relative to one another;wherein the original shape defines an original angle of the upperportion relative to the lower portion along the length within the rangeof 80° to 90°, and the therapeutic angle is defined as being the same asor different from the original angle and within the range of 80° to 90°.2. The orthopedic device according to claim 1, wherein the intermediateportion defines an upper neck and a lower neck, and a bulbous widthportion located between the upper and lower necks which each reducematerial of the width of the intermediate portion relative to thebulbous width portion, the bulbous width portion generally correspondingto the bend area and symmetrically extends outwardly in width withinfirst and second sides delimited by the rigid edges of the intermediateportion.
 3. The orthopedic device according to claim 2, wherein the edgeovermold forms flaps on opposed sides along peripheries of the upper andlower necks having a larger portions than at the bulbous width portion.4. The orthopedic device according to claim 1, wherein the splint memberdefines a recessed portion located around the bend area and arranged forfacilitating bending of the stay, wherein the recessed portion isdefined along the anterior surface of the splint member between rigidedges of the intermediate portion.
 5. The orthopedic device according toclaim 1, wherein a shape configuration of the lower portion remainingsubstantially the same as the stay is bent.
 6. The orthopedic deviceaccording to claim 1, wherein the stay is more rigid than the splintmember.
 7. The orthopedic device according to claim 1, wherein theorthopedic device includes at least one opening extending through athickness of the splint member and the stay.
 8. The orthopedic deviceaccording to claim 1, wherein the stay continuously extends along alength and through the upper, intermediate and lower portions of thesplint member.
 9. The orthopedic device according to claim 1, whereinthe stay slightly bulges along lines formed by the intermediate portionand along the posterior surface of the orthopedic device within theconcave shape.
 10. An orthopedic device, comprising: a splint memberbeing substantially rigid and formed from a thermoplastic orthermosetting polymer, the splint member defining anterior and posteriorsurfaces, and peripheral surfaces, the splint member having an originalshape wherein the splint member defines along a length of the splintmember an upper portion, an intermediate portion and a lower portion,and in the original shape the posterior surface of the splint member hasa concave shape and at least in the intermediate and upper portionsalong the length of the splint member, and the splint member has rigidedges which are hard; a stay being bendable aluminum metal embedded inthe splint member between the anterior and posterior surfaces and withinthe intermediate portion of the splint member, the stay arranged tomaintain a shape when the orthopedic device is worn by a wearer, andwherein the stay is bendable to place the splint member into a modifiedshape different from the original shape; wherein the splint member andthe stay collectively form a bend area located only within theintermediate portion of the splint member such that the stay is bendableat the bend area in order to custom-fit or modify a therapeutic angle ofthe splint member within the intermediate portion by arranging the upperand lower portions relative to one another; wherein the original shapedefines an original angle of the upper portion relative to the lowerportion along the length within the range of 80° to 90°, and thetherapeutic angle is defined as being the same as or different from theoriginal angle and within the range of 80° to 90°.
 11. The orthopedicdevice according to claim 10, wherein the lower portion defines a flareddistal end portion.
 12. The orthopedic device according to claim 11,wherein the lower portion defines venting through slots extendingthrough the entirety of the splint member.
 13. The orthopedic deviceaccording to claim 10, wherein the stay slightly bulges along linesformed by the intermediate portion and along the posterior surface ofthe orthopedic device within the concave shape.
 14. The orthopedicdevice according to claim 10, wherein the intermediate portion definesan upper neck and a lower neck, and a bulbous width portion locatedbetween the upper and lower necks which each reduce material of thewidth of the intermediate portion relative to the bulbous width portion,the bulbous width portion generally corresponding to the bend area andsymmetrically extends outwardly in width within first and second sidesdelimited by the rigid edges of the intermediate portion.
 15. Anorthopedic device, comprising: a splint member being substantially rigidand formed from a thermoplastic or thermosetting polymer, the splintmember defining anterior and posterior surfaces, the splint memberhaving an original shape, wherein the splint member defines along alength of the splint member an upper portion, an intermediate portionand a lower portion, and in the original shape the posterior surface ofthe splint member has a concave shape, and the splint member has rigidedges which are hard; an edge overmold being flexible and integrallysecured along at least a portion of the rigid edges of the splintmember, the edge overmold extending outwardly from the periphery of thesplint member and having greater flexibility than the splint member; astay being formed from a bendable aluminum metal embedded in the splintmember between the anterior and posterior surfaces and within theintermediate portion of the splint member, the stay arranged to maintaina shape when the orthopedic device is worn by a wearer, and wherein thestay is bendable to place the splint member into a modified shapedifferent from the original shape; wherein the edge overmold extendsalong the hard and rigid edges at the upper and intermediate portions ofthe splint member, the lower portion defines a flared distal end portiondevoid of the edge overmold.